A Prospective Cohort Study on Colorectal Cancer Screening in Community Population

NCT ID: NCT05485077

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 18000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-09
• Study Completion Date: 2028-07-09

Brief Summary

This study will validate the real world results of polygene methylation detection in colorectal cancer in a large prospective community cohort. In this study, questionnaire survey and polygene methylation detection technology of colorectal cancer were used as preliminary screening methods, and colonoscopy was used as further validation examination method to screen colorectal cancer and precancerous lesions. The diagnosis and outcome of all lesions were based on colonoscopy and pathological examination.

Detailed Description

1. The informed consent signed by shougang Community will be completed in the baseline period: Colorectal cancer risk factors assessment questionnaire, medical history collection, fecal immunochemical (FIT), carcinoembryonic antigen (CEA) blood test and blood bowel cancer gene methylation detection, for colorectal cancer gene methylation detection results more positive subjects and the result of the negative part of the subjects (n = 500), within 3 months after receiving the results complete colonoscopy.

2. Follow-up at 1, 2, 3, 4, and 5 years after baseline included: ① Central follow-up at 1, 3, and 5 years: history collection, colonoscopy, FIT test, and CEA examination; ② Telephone follow-up at the 2nd and 4th years: medical history was collected; (3) Survival outcome registration was performed in the fifth year; Follow-up history was collected at 1, 2, 3, 4, and 5 years after completion of baseline, and survival outcomes were registered at 5 years.

3. During the follow-up, the subjects were confirmed to be diagnosed with colorectal cancer by evaluation (colorectal cancer was diagnosed by colonoscopy), and the subjects who were treated after polyps or adenomas were found during colonoscopy also reached the study endpoint.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Positive group

All the subjects who completed colorectal cancer polygene methylation test at baseline completed colonoscopy within 3 months. Colorectal cancer diagnosed by colonoscopy, adenoma or polyp lesions found after treatment will reach the end of the study. The tumor history of family members was tracked for patients who met the end point of the study. The positive subjects who did not reach the end point of the study underwent three center visits at 12, 36 and 60 months after enrollment respectively, including history taking, colonoscopy, FIT test and blood CEA test. Another telephone follow-up was conducted at 24 and 48 months, respectively.

No interventions assigned to this group

Negative group

The subjects who completed colorectal cancer polygene methylation test at baseline, and those with negative test results (n= 500, direct extraction method) completed colonoscopy within 3 months. The end points and follow-up were the same as those in the positive group. The negative group was compared with the positive group to observe the difference of negative predictive value and survival outcome.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Chronological age ≥40 years;

2. Full capacity for action;

3. After enrollment, the participants were able to complete the Colorectal Cancer Risk Factor Assessment Questionnaire and the annual follow-up interviews;

4. In the course of the study, the information related to tumor diagnosis in other hospitals can be timely fed back to the researchers;

Exclusion Criteria

1. History of colorectal cancer and other malignant tumors;

2. Previous colorectal resection;

3. undergoing any cancer-related treatment;

4. Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months;

5. Participate in other interventional clinical investigators within 3 months;

6. Pregnant or lactating women;

7. Have autoimmune disease, hereditary disease, mental illness/disability, etc

8. Poor compliance, unable to complete the study.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Shougang Hospital

OTHER

Sponsor Role: collaborator

Singlera Genomics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Singlera Genomics Inc.

Locations

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jin Gu, Doctor

Role: CONTACT

yuanping_632@163.com

010-57830127

Ping Yuan

Role: CONTACT

15210919487

Facility Contacts

Jin Gu, Doctor

Role: primary

yuanping_632@163.com

010-57830127

Ping Yuan

Role: backup

15210919487

References

Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Flejou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastrointestinal epithelial neoplasia. Gut. 2000 Aug;47(2):251-5. doi: 10.1136/gut.47.2.251.

Reference Type: BACKGROUND

PMID: 10896917 (View on PubMed)

Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6.

Reference Type: BACKGROUND

PMID: 28263317 (View on PubMed)

Cai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available.

Reference Type: BACKGROUND

PMID: 34487783 (View on PubMed)

Other Identifiers

KYS-2022007

Identifier Type: -

Identifier Source: org_study_id