A Prospective Cohort Study on Colorectal Cancer Screening in Community Population

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Screening Cohort Study in Shougang Community Population Based on Polygene Methylation Detection Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485077
• Other study ID #: KYS-2022007
• Status: Recruiting
• Start date: July 9, 2022
• Est. completion date: July 9, 2028

Study information

• Verified date: April 2024
• Source: Singlera Genomics Inc.
• Contact: Jin Gu, Doctor
• Phone: 010-57830127
• Email: yuanping_632[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18000
• Est. completion date: July 9, 2028
• Est. primary completion date: July 9, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
China	Peking University Shougang Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Singlera Genomics Inc.	Peking University Shougang Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of polygene methylation detection in colorectal cancer	To investigate the sensitivity and specificity of polygene methylation in the diagnosis of colorectal cancer in community population, and to evaluate its value as an auxiliary diagnosis	assessed up to 72 months
Primary	Negative predictive value and positive predictive value of polygene methylation in colorectal cancer	To obtain the positive predictive value and negative predictive value of polygene methylation test for colorectal cancer early screening, and compare with FIT test and blood CEA test.	assessed up to 72 months