A Prospective Cohort Study on Colorectal Cancer Screening in Community Population

NCT05485077 | Recruiting

• 1 other identifier: KYS-2022007
• Study Type: observational
• Target: 18,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

ctDNA methylation; Community population screening

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18000 samples from Shougang community

You may qualify if:

• Chronological age ≥40 years;
• Full capacity for action;
• After enrollment, the participants were able to complete the Colorectal Cancer Risk Factor Assessment Questionnaire and the annual follow-up interviews;
• In the course of the study, the information related to tumor diagnosis in other hospitals can be timely fed back to the researchers;

You may not qualify if:

• History of colorectal cancer and other malignant tumors;
• Previous colorectal resection;
• undergoing any cancer-related treatment;
• Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months;
• Participate in other interventional clinical investigators within 3 months;
• Pregnant or lactating women;
• Have autoimmune disease, hereditary disease, mental illness/disability, etc
• Poor compliance, unable to complete the study.

Sponsors & Collaborators

• Singlera Genomics Inc.: lead
• Peking University Shougang Hospital: collaborator

Study Sites (1)

Peking University Shougang Hospital

Beijing, Beijing Municipality, 100144, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 10896917 BACKGROUND

• 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.

  PMID: 28263317 BACKGROUND

• 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.

  PMID: 34487783 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rui Liu, Doctor

  Singlera Genomics Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Gu, Doctor

CONTACT

010-57830127; yuanping_632@163.com

Ping Yuan

CONTACT

15210919487

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 3, 2022
• Study Start: July 9, 2022
• Primary Completion (Estimated): July 9, 2028
• Study Completion (Estimated): July 9, 2028
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)