Evaluation of Some Risk Factors Associated With Colorectal Cancer
NCT ID: NCT05170360
Last Updated: 2021-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-12-31
2023-12-31
Brief Summary
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2. Estimation of KRAS and BRAF genes mutations associated with CRC.
3. Association between different risk factors and gene mutations on different types of CRC.
Detailed Description
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* Studies have provided that rising CRC rates are associated with increased alcohol use, physical inactivity, high intake of fat, red and processed meat, and processed foods; and low intake of fiber (Zhou and Rifkin, 2021).
* Smoking is an established risk factor for colorectal adenomas as well as CRC incidence and mortality, which suggests that it may affect the prognosis of CRC patients as well (Walter et al., 2014).
* Heavy metals are natural components of the earth's crust, which, if released into the environment, can persist for many years (Wu et al., 2016). The most toxic elements are arsenic, cadmium, chromium, copper, mercury, and lead with the majority of them being classified as certainly or probably carcinogenic (Forte et al., 2020).
* Pesticides that are applied to farms can remain in the environment for longer than intended (Sjerps et al., 2019). Pesticides increase the risk of cancer through a variety of mechanisms including genotoxicity, epigenetic effects, hormonal action, and immunotoxicity (Lyons and Watterson, 2010).
* Of the key genes of CRC, KRAS mutations are the most widely known, as they are mainly localized in codons 12 and 13, which were among the first linked to the pathogenesis of colon cancer (Kudryavtseva et al., 2016). BRAF is an oncogene located on chromosome 7 for which gain of function mutations in multiple solid tumors, such as colon cancer (Frisone et al., 2020).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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patient group
Patients who are recently diagnosed with CRC based on clinical and pathological examinations
Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:
1. Assessment of smoking exposure:
Serum cotinine will be measured by using serum cotinine ELISA kits
2. Assessment of heavy metal exposure:
Lead and cadmium will be measured using Graphite Tube Atomizer.
3. Assessment of organophosphorus exposure:
By measuring pseudocholinesterase level by spectrophotometer
4. Mutational analysis of the KRAS and BRAF genes:
the tissue samples will be used to determine the mutation in k-ras and BRAF genes by RCR
control group
Control subjects will be CRC-free, based on the clinical history and physical examination.
Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:
1. Assessment of smoking exposure:
Serum cotinine will be measured by using serum cotinine ELISA kits
2. Assessment of heavy metal exposure:
Lead and cadmium will be measured using Graphite Tube Atomizer.
3. Assessment of organophosphorus exposure:
By measuring pseudocholinesterase level by spectrophotometer
4. Mutational analysis of the KRAS and BRAF genes:
the tissue samples will be used to determine the mutation in k-ras and BRAF genes by RCR
Interventions
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Assessment of smoking ,heavy metal, organophosphorus exposure and d) Mutational analysis of the KRAS and BRAF genes:
1. Assessment of smoking exposure:
Serum cotinine will be measured by using serum cotinine ELISA kits
2. Assessment of heavy metal exposure:
Lead and cadmium will be measured using Graphite Tube Atomizer.
3. Assessment of organophosphorus exposure:
By measuring pseudocholinesterase level by spectrophotometer
4. Mutational analysis of the KRAS and BRAF genes:
the tissue samples will be used to determine the mutation in k-ras and BRAF genes by RCR
Eligibility Criteria
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Inclusion Criteria
2\. Control subjects will be CRC-free, based on the clinical history and physical examination.
Exclusion Criteria
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Sarah Abdelsamee Mohammed Ali
Assistant lecturer in Forensic Medicine and Clinical Toxicology Department
Principal Investigators
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Hayam Z Thabet, prof.DR
Role: STUDY_DIRECTOR
Assiut University
Heba A. Yassa, prof.DR
Role: STUDY_DIRECTOR
Assiut University
Central Contacts
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References
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Erratum: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2020 Jul;70(4):313. doi: 10.3322/caac.21609. Epub 2020 Apr 6. No abstract available.
Forte IM, Indovina P, Costa A, Iannuzzi CA, Costanzo L, Marfella A, Montagnaro S, Botti G, Bucci E, Giordano A. Blood screening for heavy metals and organic pollutants in cancer patients exposed to toxic waste in southern Italy: A pilot study. J Cell Physiol. 2020 Jun;235(6):5213-5222. doi: 10.1002/jcp.29399. Epub 2019 Dec 15.
Kudryavtseva AV, Lipatova AV, Zaretsky AR, Moskalev AA, Fedorova MS, Rasskazova AS, Shibukhova GA, Snezhkina AV, Kaprin AD, Alekseev BY, Dmitriev AA, Krasnov GS. Important molecular genetic markers of colorectal cancer. Oncotarget. 2016 Aug 16;7(33):53959-53983. doi: 10.18632/oncotarget.9796.
Nanda MS, Sameer AS, Syeed N, Shah ZA, Murtaza I, Siddiqi MA, Ali A. Genetic aberrations of the K-ras proto-oncogene in bladder cancer in Kashmiri population. Urol J. 2010 Summer;7(3):168-73.
Przybojewska B, Jagiello A, Jalmuzna P. H-RAS, K-RAS, and N-RAS gene activation in human bladder cancers. Cancer Genet Cytogenet. 2000 Aug;121(1):73-7. doi: 10.1016/s0165-4608(00)00223-5.
Frisone D, Friedlaender A, Malapelle U, Banna G, Addeo A. A BRAF new world. Crit Rev Oncol Hematol. 2020 Aug;152:103008. doi: 10.1016/j.critrevonc.2020.103008. Epub 2020 May 26.
Sjerps RMA, Kooij PJF, van Loon A, Van Wezel AP. Occurrence of pesticides in Dutch drinking water sources. Chemosphere. 2019 Nov;235:510-518. doi: 10.1016/j.chemosphere.2019.06.207. Epub 2019 Jun 27.
Walter V, Jansen L, Hoffmeister M, Brenner H. Smoking and survival of colorectal cancer patients: systematic review and meta-analysis. Ann Oncol. 2014 Aug;25(8):1517-25. doi: 10.1093/annonc/mdu040. Epub 2014 Mar 31.
Wu X, Cobbina SJ, Mao G, Xu H, Zhang Z, Yang L. A review of toxicity and mechanisms of individual and mixtures of heavy metals in the environment. Environ Sci Pollut Res Int. 2016 May;23(9):8244-59. doi: 10.1007/s11356-016-6333-x. Epub 2016 Mar 11.
Zhou E, Rifkin S. Colorectal Cancer and Diet: Risk Versus Prevention, Is Diet an Intervention? Gastroenterol Clin North Am. 2021 Mar;50(1):101-111. doi: 10.1016/j.gtc.2020.10.012.
Other Identifiers
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colorectal cancer risk factors
Identifier Type: -
Identifier Source: org_study_id