Validation of Advanced Colorectal Neoplasm Risk Categories in a Prospective Cohort in Mexico
NCT ID: NCT05661292
Last Updated: 2023-01-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Total Enrollment
2000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-08-01
Study Completion Date
2025-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Worldwide, there are 1,361,000 new cases of colorectal cancers (CRC) annually, with 694,000 deaths. However, the incidence varies by up to a factor of 10x between high and low incidence countries (eg. USA vs Mexico, incidence rate of 42.54 vs 7.44 / 100,000 inhabitants). Mexico is considered a low-incidence country, with 8,651 new cases and 4,694 deaths annually.
CRC is a preventable and detectable disease. Screening programs established in high-incidence countries have managed to reduce the incidence and mortality from this disease and it is considered a cost-effective strategy. In less developed countries where there are no screening programs for CRC, the highest number of deaths occurs despite having the lowest number of cases. It is recognized that a barrier to establishing a screening program in a country with low incidence and limited resources is cost-effectiveness.
The prevalence of Advanced Colorectal Neoplasia (ACN) detected by screening colonoscopy in a Mexican cohort of 1172 INNSZ patients was 2.9%. In the US the prevalence is 7.6%. The number of colonoscopies to be performed to detect ACN was estimated at 34 for Mexico and 13 for the US, which suggests that the cost-effectiveness of screening colonoscopy could be 3 times lower in our country.
In Mexico there is no national screening program for CRC. The eligible population (adults between 50 and 75 years old) for CRC screening is estimated in 20 million of Mexicans. It is recognized that Mexico does not have enough financial resources nor the infrastructure to screen the entire eligible population either by direct colonoscopy, or by FIT (fecal immunochemical test) followed by colonoscopy. With a 5% frequency of positive FIT, nearly 1,000,000 follow-up colonoscopies would be required annually in a population screening program.
An alternative could be to offer screening based on risk, which means only offering screening to the highest-risk population.
There are calculators to predict the risk of identifying ACN in a screening colonoscopy, however, none have been developed and validated in the Mexican population. The weight of the risk factors associated with ACN in the Mexican population could be different, so it is necessary to develop and validate an ACN risk calculator that allows the Mexican population to be stratified and to concentrate screening efforts on the population at highest risk.
CRC is a preventable and detectable disease. Screening programs established in high-incidence countries have managed to reduce the incidence and mortality from this disease and it is considered a cost-effective strategy. In less developed countries where there are no screening programs for CRC, the highest number of deaths occurs despite having the lowest number of cases. It is recognized that a barrier to establishing a screening program in a country with low incidence and limited resources is cost-effectiveness.
The prevalence of Advanced Colorectal Neoplasia (ACN) detected by screening colonoscopy in a Mexican cohort of 1172 INNSZ patients was 2.9%. In the US the prevalence is 7.6%. The number of colonoscopies to be performed to detect ACN was estimated at 34 for Mexico and 13 for the US, which suggests that the cost-effectiveness of screening colonoscopy could be 3 times lower in our country.
In Mexico there is no national screening program for CRC. The eligible population (adults between 50 and 75 years old) for CRC screening is estimated in 20 million of Mexicans. It is recognized that Mexico does not have enough financial resources nor the infrastructure to screen the entire eligible population either by direct colonoscopy, or by FIT (fecal immunochemical test) followed by colonoscopy. With a 5% frequency of positive FIT, nearly 1,000,000 follow-up colonoscopies would be required annually in a population screening program.
An alternative could be to offer screening based on risk, which means only offering screening to the highest-risk population.
There are calculators to predict the risk of identifying ACN in a screening colonoscopy, however, none have been developed and validated in the Mexican population. The weight of the risk factors associated with ACN in the Mexican population could be different, so it is necessary to develop and validate an ACN risk calculator that allows the Mexican population to be stratified and to concentrate screening efforts on the population at highest risk.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ColoRectal Cancer Screening for Southern California Community Health Centers
NCT04941300
Colorectal Cancer
COMPLETED
PHASE3
Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
NCT06703632
Screening for Colon Cancer
Blood Samples
Survey and Questionnaire
+3 more
RECRUITING
NA
Systems Intervention to Promote Colorectal Cancer (CRC) Screening
NCT01299493
Carcinoma
COMPLETED
NA
Gut Microbiota and Color-rectal Cancer.
NCT04662853
Cancer
Colo-rectal Cancer
Diagnoses Disease
+2 more
UNKNOWN
Confronting Cancer as a Community
NCT06063928
Colorectal Carcinoma
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a prospective cohort of subjects eligible for CRC screening in Mexico City.
The main goal is to validate the APCS clinical score as a risk - stratification tool for screening colonoscopy in a Mexican population.
The Asian-Pacific Colorectal Screening (APCS) score is a clinical tool used to stratify subjects according to the probability of identification of Advanced Colorectal Neoplasia (ACN) in a screening colonoscopy. ACN includes lesions larger than 10 mm with one or more of the following: a villous content, high-grade dysplasia, or carcinoma. The tool stratifies the population into three risk categories, considering: age, sex, smoking history, and first-degree family history of colorectal cancer. The total score obtained allows the stratification into average risk (0-1 point), moderate (2-3 points), and high risk (4-7 points). The prevalence of ACN in the original validation cohort of the APCS was 1.3% for average risk, 3.2% in moderate risk and 5.2% in high risk.
Investigators previously evaluated the APCS score in a retrospective study of screening colonoscopy in Mexican population (n=1269). The prevalence of ACN was 2.6% vs 5.2% (p=0.027) for moderate risk and high-risk categories, respectively.
To implement a risk-stratified screening program for the Mexican population, prospective validation was considered necessary. A prospective study would allow for collection and evaluation of additional variables that could potentially improve APCS score. FIT cut-off values have never been validated in Mexican population and are required to implement a national colorectal screening program. Prospective design will also allow for bio banking for future medical research.
The following procedures will be performed:
1. Subjects will be invited to participate in the study, and if they accept, an informed consent will be given and explained to them. They will have a standardized interview dedicated to promoting CRC screening and complete a CRC risk factor questionnaire to determine their risk category.
2. Subjects may optionally participate in the collection of tissue, blood, and urine samples for future biomedical research. This procedure consists of taking a 15 ml sample of venous blood and 20 ml of urine. The tissue samples to be used will be those that have been taken for diagnostic purposes during the colonoscopy. Additional biopsies not required for medical care will not be taken. These samples will be used as long as they are no longer required to establish a diagnosis.
3. A Fecal Immunochemical Test (FIT) will be performed prior to the colonoscopy. Note: A positive FIT will have a Hb value \>20 ug/g of stool.
4. A colonoscopy will be performed. Any polyp identified will be resected (polypectomy) and analyzed histologically. NOTE: The subject and physician will be blinded to FIT test results and risk category.
In subsequent medical consultation, the results of the risk score, the FIT test, and colonoscopy will be discussed.
5. If the patient does not perform any of the tests, they will be interviewed on a second occasion to complete a questionnaire of reasons of rejection. NOTE: It is anticipated that a proportion of subjects will verbally accept the screening, but the proposed tests will not be carried out (this will measure the percentage of acceptance of the recommendation).
Given that age and gender are the most important risk factors, the population will be stratified simulating the Mexican population pyramid as follows: 50% male subjects and 50% female subjects. By age groups: 50-54 years (31%), 55-59 (24%), 60-64 (19%), 65-69 (14%), 70-75 (12%).
The data collected from the participants will be entered into an electronic registry (Redcap) in real-time. A periodic review of the electronic registry will be carried out by personal of the protocol to ensure the quality of the information and that it is complete. The study does not contemplate external monitoring of the data.
Statistical considerations
* Sample size: for a difference in proportions of 2.6% (prevalence of ACN 5.2% vs. 2.6% in the high vs. moderate-risk population), 868 subjects per group are required to achieve a power of 80%, with a confidence level of 95 %, that is, 1736 subjects. It is anticipated that in 15% of the subjects the two screening tests will not be available, so a total sample of 2000 subjects is proposed.
* Statistical proportions, means, and medians will be used to describe the population. The differences in proportions will be analyzed with the X2 test. Using a binary logistic regression model, variables associated with ACN risk will be identified. A p \< 0.05 will be considered statistically significant. The risk calculator will be developed using the variables identified in the univariate analysis and differential weight will be assigned to them according to risk. To determine the optimal cut-off point in FIT test (ng of hemoglobin per gram of feces): the investigators will use the distribution of the FIT score for patients with and without premalignant lesions and/or colorectal cancer to estimate sensitivity and specificity. according to different cut-off values. Subsequently, the investigators will use a decision model based on specificity/sensitivity ROC curves and according to different FIT cut-off points. The closer the ROC curve is to the upper left corner, the higher the predictive power of detecting colorectal lesions.
The main goal is to validate the APCS clinical score as a risk - stratification tool for screening colonoscopy in a Mexican population.
The Asian-Pacific Colorectal Screening (APCS) score is a clinical tool used to stratify subjects according to the probability of identification of Advanced Colorectal Neoplasia (ACN) in a screening colonoscopy. ACN includes lesions larger than 10 mm with one or more of the following: a villous content, high-grade dysplasia, or carcinoma. The tool stratifies the population into three risk categories, considering: age, sex, smoking history, and first-degree family history of colorectal cancer. The total score obtained allows the stratification into average risk (0-1 point), moderate (2-3 points), and high risk (4-7 points). The prevalence of ACN in the original validation cohort of the APCS was 1.3% for average risk, 3.2% in moderate risk and 5.2% in high risk.
Investigators previously evaluated the APCS score in a retrospective study of screening colonoscopy in Mexican population (n=1269). The prevalence of ACN was 2.6% vs 5.2% (p=0.027) for moderate risk and high-risk categories, respectively.
To implement a risk-stratified screening program for the Mexican population, prospective validation was considered necessary. A prospective study would allow for collection and evaluation of additional variables that could potentially improve APCS score. FIT cut-off values have never been validated in Mexican population and are required to implement a national colorectal screening program. Prospective design will also allow for bio banking for future medical research.
The following procedures will be performed:
1. Subjects will be invited to participate in the study, and if they accept, an informed consent will be given and explained to them. They will have a standardized interview dedicated to promoting CRC screening and complete a CRC risk factor questionnaire to determine their risk category.
2. Subjects may optionally participate in the collection of tissue, blood, and urine samples for future biomedical research. This procedure consists of taking a 15 ml sample of venous blood and 20 ml of urine. The tissue samples to be used will be those that have been taken for diagnostic purposes during the colonoscopy. Additional biopsies not required for medical care will not be taken. These samples will be used as long as they are no longer required to establish a diagnosis.
3. A Fecal Immunochemical Test (FIT) will be performed prior to the colonoscopy. Note: A positive FIT will have a Hb value \>20 ug/g of stool.
4. A colonoscopy will be performed. Any polyp identified will be resected (polypectomy) and analyzed histologically. NOTE: The subject and physician will be blinded to FIT test results and risk category.
In subsequent medical consultation, the results of the risk score, the FIT test, and colonoscopy will be discussed.
5. If the patient does not perform any of the tests, they will be interviewed on a second occasion to complete a questionnaire of reasons of rejection. NOTE: It is anticipated that a proportion of subjects will verbally accept the screening, but the proposed tests will not be carried out (this will measure the percentage of acceptance of the recommendation).
Given that age and gender are the most important risk factors, the population will be stratified simulating the Mexican population pyramid as follows: 50% male subjects and 50% female subjects. By age groups: 50-54 years (31%), 55-59 (24%), 60-64 (19%), 65-69 (14%), 70-75 (12%).
The data collected from the participants will be entered into an electronic registry (Redcap) in real-time. A periodic review of the electronic registry will be carried out by personal of the protocol to ensure the quality of the information and that it is complete. The study does not contemplate external monitoring of the data.
Statistical considerations
* Sample size: for a difference in proportions of 2.6% (prevalence of ACN 5.2% vs. 2.6% in the high vs. moderate-risk population), 868 subjects per group are required to achieve a power of 80%, with a confidence level of 95 %, that is, 1736 subjects. It is anticipated that in 15% of the subjects the two screening tests will not be available, so a total sample of 2000 subjects is proposed.
* Statistical proportions, means, and medians will be used to describe the population. The differences in proportions will be analyzed with the X2 test. Using a binary logistic regression model, variables associated with ACN risk will be identified. A p \< 0.05 will be considered statistically significant. The risk calculator will be developed using the variables identified in the univariate analysis and differential weight will be assigned to them according to risk. To determine the optimal cut-off point in FIT test (ng of hemoglobin per gram of feces): the investigators will use the distribution of the FIT score for patients with and without premalignant lesions and/or colorectal cancer to estimate sensitivity and specificity. according to different cut-off values. Subsequently, the investigators will use a decision model based on specificity/sensitivity ROC curves and according to different FIT cut-off points. The closer the ROC curve is to the upper left corner, the higher the predictive power of detecting colorectal lesions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Colorectal Cancer Screening
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fecal inmunochemical test
A fecal inmunochemical test will be performed prior to colonoscopy.
Intervention Type
DIAGNOSTIC_TEST
Colonoscopy
A colonoscopy will be performed. Any polyp identified will be resected (polypectomy) and analyzed histologically. NOTE: The subject and colonoscopist will be blinded to FIT test results and risk category.
Intervention Type
DIAGNOSTIC_TEST
Optional collection of tissue, blood and urine for future biomedical research
Subjects may optionally participate in the collection of tissue, blood, and urine samples for future biomedical research. This procedure consists of taking a 15 ml sample of venous blood and 20 ml of urine. The tissue samples to be used will be those that have been taken for diagnostic purposes during the colonoscopy. Additional biopsies not required for medical care will not be taken. These samples will be used as long as they are no longer required to establish a diagnosis.
Intervention Type
BIOLOGICAL
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
FIT
Tissue, blood and urine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Asymptomatic subjects between 50 and 75 years of age-eligible for CRC screening with or without registry at the institute.
Note: concerning symptoms of CRC diagnosis will not be admitted: fresh blood in the stool, black stools, unexplained weight loss (\>10% of usual body weight). Concerning symptoms of Functional Gastrointestinal Disorder (FGID) will be permitted: loss of appetite, diarrhea, constipation, abdominal pain or discomfort.
* Subjects who give their informed consent.
* Subjects who have completed the vaccination schedule against the SARS CoV-2 virus with any of the vaccines approved in Mexico, at least 4 weeks before the colonoscopy.
Note: concerning symptoms of CRC diagnosis will not be admitted: fresh blood in the stool, black stools, unexplained weight loss (\>10% of usual body weight). Concerning symptoms of Functional Gastrointestinal Disorder (FGID) will be permitted: loss of appetite, diarrhea, constipation, abdominal pain or discomfort.
* Subjects who give their informed consent.
* Subjects who have completed the vaccination schedule against the SARS CoV-2 virus with any of the vaccines approved in Mexico, at least 4 weeks before the colonoscopy.
Exclusion Criteria
* Personal history of any type of cancer, except basal cell carcinoma or cervical cancer in situ.
* Personal history of colon polyps.
* Personal history of abdominal or pelvic radiation due to previous cancer.
* Relatives with familial adenomatous polyposis (FAP) or hereditary non-polyposis CRC.
* Inflammatory bowel disease (IBD).
* High anesthetic risk (ASA greater than 3 of the classification of the American Society of Anesthesiology).
* Any medical condition that limits life expectancy at the discretion of the investigator.
* Charlson index \> 4.
* Presence of anemia in the last year according to the WHO definition: women \<12 g/dl, men \<13 g/dl.
* Previous colectomy.
* Colonoscopy in the previous 5 years.
* Sigmoidoscopy in the previous 3 years.
* A fecal occult blood test in the past year.
* CT colonography in the previous 10 years.
* Clinical data suggestive of CRC such as hematochezia, melena, weight loss greater than 10% of usual body weight in a 6 months period.
* Personal history of colon polyps.
* Personal history of abdominal or pelvic radiation due to previous cancer.
* Relatives with familial adenomatous polyposis (FAP) or hereditary non-polyposis CRC.
* Inflammatory bowel disease (IBD).
* High anesthetic risk (ASA greater than 3 of the classification of the American Society of Anesthesiology).
* Any medical condition that limits life expectancy at the discretion of the investigator.
* Charlson index \> 4.
* Presence of anemia in the last year according to the WHO definition: women \<12 g/dl, men \<13 g/dl.
* Previous colectomy.
* Colonoscopy in the previous 5 years.
* Sigmoidoscopy in the previous 3 years.
* A fecal occult blood test in the past year.
* CT colonography in the previous 10 years.
* Clinical data suggestive of CRC such as hematochezia, melena, weight loss greater than 10% of usual body weight in a 6 months period.
Minimum Eligible Age
50 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Conquer Cancer Foundation
OTHER
Sponsor Role
collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Huitzil m
Medical Doctor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fidel D Huitzil-Melendez, MS
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Ciencias Médicas y Nutrición
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, , Mexico
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Mexico
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Allison JE, Fraser CG, Halloran SP, Young GP. Population screening for colorectal cancer means getting FIT: the past, present, and future of colorectal cancer screening using the fecal immunochemical test for hemoglobin (FIT). Gut Liver. 2014 Mar;8(2):117-30. doi: 10.5009/gnl.2014.8.2.117. Epub 2014 Mar 11.
Reference Type
BACKGROUND
Baxter NN, Warren JL, Barrett MJ, Stukel TA, Doria-Rose VP. Association between colonoscopy and colorectal cancer mortality in a US cohort according to site of cancer and colonoscopist specialty. J Clin Oncol. 2012 Jul 20;30(21):2664-9. doi: 10.1200/JCO.2011.40.4772. Epub 2012 Jun 11.
Reference Type
BACKGROUND
Brenner H, Chang-Claude J, Rickert A, Seiler CM, Hoffmeister M. Risk of colorectal cancer after detection and removal of adenomas at colonoscopy: population-based case-control study. J Clin Oncol. 2012 Aug 20;30(24):2969-76. doi: 10.1200/JCO.2011.41.3377. Epub 2012 Jul 23.
Reference Type
BACKGROUND
Bujanda L, Cosme A, Gil I, Arenas-Mirave JI. Malignant colorectal polyps. World J Gastroenterol. 2010 Jul 7;16(25):3103-11. doi: 10.3748/wjg.v16.i25.3103.
Reference Type
BACKGROUND
Chiang TH, Chuang SL, Chen SL, Chiu HM, Yen AM, Chiu SY, Fann JC, Chou CK, Lee YC, Wu MS, Chen HH. Difference in performance of fecal immunochemical tests with the same hemoglobin cutoff concentration in a nationwide colorectal cancer screening program. Gastroenterology. 2014 Dec;147(6):1317-26. doi: 10.1053/j.gastro.2014.08.043. Epub 2014 Sep 6.
Reference Type
BACKGROUND
Coleman HG, Loughrey MB, Murray LJ, Johnston BT, Gavin AT, Shrubsole MJ, Bhat SK, Allen PB, McConnell V, Cantwell MM. Colorectal Cancer Risk Following Adenoma Removal: A Large Prospective Population-Based Cohort Study. Cancer Epidemiol Biomarkers Prev. 2015 Sep;24(9):1373-80. doi: 10.1158/1055-9965.EPI-15-0085. Epub 2015 Jun 16.
Reference Type
BACKGROUND
Eduardo Negrete Carballo, Fidel David Huitzil Melendez. Prevalence of advanced colorectal neoplasia according to risk categories at screening colonoscopy in a tertiary referral center. Journal of Clinical Oncology 36, no. 4_suppl (February 2018) 578-578. DOI: 10.1200/JCO.2018.36.4_suppl.578.
Reference Type
BACKGROUND
Freedman AN, Slattery ML, Ballard-Barbash R, Willis G, Cann BJ, Pee D, Gail MH, Pfeiffer RM. Colorectal cancer risk prediction tool for white men and women without known susceptibility. J Clin Oncol. 2009 Feb 10;27(5):686-93. doi: 10.1200/JCO.2008.17.4797. Epub 2008 Dec 29.
Reference Type
BACKGROUND
Flitcroft KL, Irwig LM, Carter SM, Salkeld GP, Gillespie JA. Colorectal cancer screening: why immunochemical fecal occult blood tests may be the best option. BMC Gastroenterol. 2012 Dec 29;12:183. doi: 10.1186/1471-230X-12-183.
Reference Type
BACKGROUND
Fraser CG, Allison JE, Halloran SP, Young GP; Expert Working Group on Fecal Immunochemical Tests for Hemoglobin, Colorectal Cancer Screening Committee, World Endoscopy Organization. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. J Natl Cancer Inst. 2012 Jun 6;104(11):810-4. doi: 10.1093/jnci/djs190. Epub 2012 Apr 2.
Reference Type
BACKGROUND
Guy GP Jr, Richardson LC, Pignone MP, Plescia M. Costs and benefits of an organized fecal immunochemical test-based colorectal cancer screening program in the United States. Cancer. 2014 Aug 1;120(15):2308-15. doi: 10.1002/cncr.28724. Epub 2014 Apr 15.
Reference Type
BACKGROUND
Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, Cid L, Castro I, de Castro L, Vega P, Hermo JA, Macenlle R, Martinez-Turnes A, Martinez-Ares D, Estevez P, Cid E, Vidal MC, Lopez-Martinez A, Hijona E, Herreros-Villanueva M, Bujanda L, Rodriguez-Prada JI; COLONPREV Study Investigators. Fecal immunochemical test accuracy in average-risk colorectal cancer screening. World J Gastroenterol. 2014 Jan 28;20(4):1038-47. doi: 10.3748/wjg.v20.i4.1038.
Reference Type
BACKGROUND
Hol L, van Leerdam ME, van Ballegooijen M, van Vuuren AJ, van Dekken H, Reijerink JC, van der Togt AC, Habbema JD, Kuipers EJ. Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy. Gut. 2010 Jan;59(1):62-8. doi: 10.1136/gut.2009.177089.
Reference Type
BACKGROUND
Hol L, Wilschut JA, van Ballegooijen M, van Vuuren AJ, van der Valk H, Reijerink JC, van der Togt AC, Kuipers EJ, Habbema JD, van Leerdam ME. Screening for colorectal cancer: random comparison of guaiac and immunochemical faecal occult blood testing at different cut-off levels. Br J Cancer. 2009 Apr 7;100(7):1103-10. doi: 10.1038/sj.bjc.6604961.
Reference Type
BACKGROUND
Howlader N, Noone AM, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2011. Bethesda MD: National Cancer Institute; 2014. http://seer.cancer.gov./csr/1975_2011/, based on November 2013 SEER data submission, posted to the SEER web site.
Reference Type
BACKGROUND
Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19.
Reference Type
BACKGROUND
Inadomi JM. Screening for Colorectal Neoplasia. N Engl J Med. 2017 Apr 20;376(16):1599-1600. doi: 10.1056/NEJMc1702535. No abstract available.
Reference Type
BACKGROUND
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
Reference Type
BACKGROUND
Jenkins PJ, Fairclough PD; British Society for Gastroenterology; Association of Coloproctology for Great Britain and Ireland. Screening guidelines for colorectal cancer and polyps in patients with acromegaly. Gut. 2002 Oct;51 Suppl 5(Suppl 5):V13-4. doi: 10.1136/gut.51.suppl_5.v13. No abstract available.
Reference Type
BACKGROUND
Langner C. Serrated and non-serrated precursor lesions of colorectal cancer. Dig Dis. 2015;33(1):28-37. doi: 10.1159/000366032. Epub 2014 Dec 17.
Reference Type
BACKGROUND
Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484.
Reference Type
BACKGROUND
Levi Z, Rozen P, Hazazi R, Vilkin A, Waked A, Maoz E, Birkenfeld S, Lieberman N, Klang S, Niv Y. Sensitivity, but not specificity, of a quantitative immunochemical fecal occult blood test for neoplasia is slightly increased by the use of low-dose aspirin, NSAIDs, and anticoagulants. Am J Gastroenterol. 2009 Apr;104(4):933-8. doi: 10.1038/ajg.2009.14. Epub 2009 Mar 17.
Reference Type
BACKGROUND
Muto T, Bussey HJ, Morson BC. The evolution of cancer of the colon and rectum. Cancer. 1975 Dec;36(6):2251-70. doi: 10.1002/cncr.2820360944.
Reference Type
BACKGROUND
Park DI, Ryu S, Kim YH, Lee SH, Lee CK, Eun CS, Han DS. Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening. Am J Gastroenterol. 2010 Sep;105(9):2017-25. doi: 10.1038/ajg.2010.179. Epub 2010 May 25.
Reference Type
BACKGROUND
Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.
Reference Type
BACKGROUND
Stegeman I, de Wijkerslooth TR, Stoop EM, van Leerdam M, van Ballegooijen M, Kraaijenhagen RA, Fockens P, Kuipers EJ, Dekker E, Bossuyt PM. Risk factors for false positive and for false negative test results in screening with fecal occult blood testing. Int J Cancer. 2013 Nov 15;133(10):2408-14. doi: 10.1002/ijc.28242. Epub 2013 Jun 25.
Reference Type
BACKGROUND
van Rossum LG, van Rijn AF, Laheij RJ, van Oijen MG, Fockens P, van Krieken HH, Verbeek AL, Jansen JB, Dekker E. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology. 2008 Jul;135(1):82-90. doi: 10.1053/j.gastro.2008.03.040. Epub 2008 Mar 25.
Reference Type
BACKGROUND
van Turenhout ST, Oort FA, Terhaar sive Droste JS, Coupe VM, van der Hulst RW, Loffeld RJ, Scholten P, Depla AC, Bouman AA, Meijer GA, Mulder CJ, van Rossum LG. Hemorrhoids detected at colonoscopy: an infrequent cause of false-positive fecal immunochemical test results. Gastrointest Endosc. 2012 Jul;76(1):136-43. doi: 10.1016/j.gie.2012.03.169.
Reference Type
BACKGROUND
Williams JG, Pullan RD, Hill J, Horgan PG, Salmo E, Buchanan GN, Rasheed S, McGee SG, Haboubi N; Association of Coloproctology of Great Britain and Ireland. Management of the malignant colorectal polyp: ACPGBI position statement. Colorectal Dis. 2013 Aug;15 Suppl 2:1-38. doi: 10.1111/codi.12262. No abstract available.
Reference Type
BACKGROUND
Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
Reference Type
BACKGROUND
Wong MC, Ching JY, Chan VC, Lam TY, Luk AK, Ng SS, Sung JJ. Factors associated with false-positive and false-negative fecal immunochemical test results for colorectal cancer screening. Gastrointest Endosc. 2015 Mar;81(3):596-607. doi: 10.1016/j.gie.2014.08.006. Epub 2014 Oct 5.
Reference Type
BACKGROUND
Yeoh KG, Ho KY, Chiu HM, Zhu F, Ching JY, Wu DC, Matsuda T, Byeon JS, Lee SK, Goh KL, Sollano J, Rerknimitr R, Leong R, Tsoi K, Lin JT, Sung JJ; Asia-Pacific Working Group on Colorectal Cancer. The Asia-Pacific Colorectal Screening score: a validated tool that stratifies risk for colorectal advanced neoplasia in asymptomatic Asian subjects. Gut. 2011 Sep;60(9):1236-41. doi: 10.1136/gut.2010.221168. Epub 2011 Mar 14.
Reference Type
BACKGROUND
Young GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, Kuipers EJ, Seaman HE. Advances in Fecal Occult Blood Tests: the FIT revolution. Dig Dis Sci. 2015 Mar;60(3):609-22. doi: 10.1007/s10620-014-3445-3. Epub 2014 Dec 10.
Reference Type
BACKGROUND
Zauber AG. The impact of screening on colorectal cancer mortality and incidence: has it really made a difference? Dig Dis Sci. 2015 Mar;60(3):681-91. doi: 10.1007/s10620-015-3600-5. Epub 2015 Mar 5.
Reference Type
BACKGROUND
Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
http://globocan.iarc.fr/Default.aspx
GLOBOCAN
https://www.inegi.org.mx/temas/estructura/
Population pyramid
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HEM-2756-18-21-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Interventions to Improve Colorectal Cancer Screening
NCT00692211
COMPLETED
NA
Microbiome Testing for the Screening of Colorectal Cancer
NCT06588166
RECRUITING
Improving Colorectal Cancer Screening for Diverse Hispanics in Urban Primary Care
NCT01569620
COMPLETED
NA
Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs
NCT01191411
COMPLETED
NA
Colorectal Cancer: Screening vs. Non-Screening
NCT02727894
COMPLETED
Time Longitudinal Study of the Microbiome in Colorectal Cancer Subjects
NCT03951792
COMPLETED
Presence of Circulating Tumor DNA in Colorectal Cancer
NCT01198743
COMPLETED
Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
NCT00906997
COMPLETED
NA
Immune Response in Peripheral Blood of Patients With Colon Cancer
NCT00900432
COMPLETED
Improving Rates of Colorectal Cancer Screening Among Never Screened Patients
NCT01742169
COMPLETED
NA
Study of Gut Microbiome and Colorectal Tumors
NCT03297996
COMPLETED
CoGENES Randomized Controlled Trial (RCT)
NCT07229443
RECRUITING
NA
Colon Cancer Screening in First-Degree Relatives of Hispanic Colorectal Cancer (CRC) Patients
NCT00838318
COMPLETED
Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion: Act Fast
NCT03789162
COMPLETED
Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
NCT02813928
COMPLETED
NA
Addressing Colorectal Cancer in South Florida Firefighters
NCT05976282
COMPLETED
NA
Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
NCT00133913
UNKNOWN
Application of FIT-DNA Detection in Following Colorectal Cancer Resection-Implications for Surveillance
NCT05528783
RECRUITING
Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM)
NCT01239082
ACTIVE_NOT_RECRUITING
NA
Clinical Application of an Automated Liquid Biopsy Platform for Early Detection of Colorectal Cancer
NCT03476122
UNKNOWN
Characterization of Brazilian Colorectal Cancer Screening Population
NCT03355391
UNKNOWN
Maximizing Yield of the Fecal Immunochemical Test for Colorectal Cancer Screening
NCT01634126
COMPLETED
EARLY_PHASE1
CARE-CRC: Microbiome Insights and Correlations for Risk and Outcomes in Colorectal Cancer
NCT06734156
NOT_YET_RECRUITING
Enhancing Prevention Pathways Toward Tribal Colorectal Health
NCT02882620
COMPLETED
NA