A Community Population Screening Cohort Study Based on Polygene Methylation Detection for Colorectal Cancer in Yangzhou

NCT05336539 | Recruiting

• 1 other identifier: PreC
• Study Type: observational
• Target: 80,000
• Locations: 1 country
• Sites: 2

Brief Summary

This is a cross-sectional cohort study based on community population jointly developed by Northern Jiangsu People's Hospital and Shanghai Kunyuan Biological Technology Co., LTD. This study will verify the real world results of polygene methylation detection of colorectal cancer in a large prospective cohort of community population, which is expected to enroll 80,000 permanent residents in Yangzhou city. The preliminary design period of the study is 5 years. In this study, questionnaire survey and polygene methylation test of colorectal cancer were used as the primary screening method, and colonoscopy was used as the 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. The evaluation indexes include sensitivity, specificity, detection rate of precancerous lesions and adenoma.

Conditions

Colorectal Cancer

Keywords

Polygenic methylation; The community crowd; Colorectal cancer screening

Outcome Measures

Primary Outcomes (2)

• Evaluation of polygenic methylation detection in colorectal cancer

  To evaluate the sensitivity, specificity, and positive/negative predictive value of polygenic methylation tests for colorectal cancer in subjects

  assessed up to 5 years

• Application value of polygene methylation detection in colorectal cancer in community population

  To verify the effectiveness and clinical value of this detection method in the diagnosis of colorectal cancer in yangzhou community population.

  assessed up to 5 years

Study Arms (1)

Positive group

subjects received colorectal cancer polygene methylation test at baseline, and all positive results were included in the positive group. They will undergo further FIT testing, blood carcinoembryonic antigen testing and colonoscopy within three months of colorectal cancer polymethylation testing.

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects of this study were permanent residents in Yangzhou who met the inclusion criteria

You may qualify if:

• \) Permanent resident population of Yangzhou; 2) Chronological age: 40\~74 years, including critical value (refer to birth date of id card); 3) Have full capacity of conduct; 4) After enrollment, they could voluntarily cooperate to complete the Colorectal cancer Risk Factor Assessment Questionnaire and accept telephone follow-up; 5) Agree to timely feed back the information related to tumor diagnosis to the investigator during the study process; 6) Willing and able to sign informed consent.

You may not qualify if:

• \) History of colorectal cancer and other malignant tumors; 2) previous colorectal resection; 3) are receiving any cancer-related treatment; 4) Those who have received major surgical treatment such as blood transfusion and transplantation within 3 months; 5) Participate in other interventional clinical investigators within 3 months; 6) Pregnant or lactating women; 7) Patients with autoimmune diseases, genetic diseases, mental diseases/disabilities and other diseases considered unsuitable for the study by the researcher; 8) Poor compliance, unable to complete the study according to the judgment of the researcher.

Sponsors & Collaborators

• Singlera Genomics Inc.: lead
• Northern Jiangsu People's Hospital: collaborator

Study Sites (2)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 201299, China

RECRUITING

Yangzhou First People's Hospital

Yangzhou, Jiangsu, 225007, China

RECRUITING

Related Publications (2)

• 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

• Wang B, Zhang Y, Liu J, Deng B, Li Q, Liu H, Sui Y, Wang N, Xiao Q, Liu W, Chen Y, Li Y, Jia H, Yuan Q, Wang C, Pan W, Li F, Yang H, Wang Y, Ding Y, Xu D, Liu R, Fang JY, Wu J. Colorectal cancer screening using a multi-locus blood-based assay targeting circulating tumor DNA methylation: a cross-sectional study in an average-risk population. BMC Med. 2024 Nov 27;22(1):560. doi: 10.1186/s12916-024-03777-2.

  PMID: 39604913 DERIVED

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

• Liu Jun, Master

  Northern Jiangsu People's Hospital，Yangzhou，China

  STUDY DIRECTOR

• Liu Rui, Doctor

  Singlera Genomics Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Jun, Master

CONTACT

18051061318; sbyy_liujun@163.com

Liu Rui, Doctor

CONTACT

rliu@singleragenomics.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)