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

Recruiting now

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT05336539

Run by

Singlera Genomics Inc.

People needed

80000

Starts

2022-04-01

Expected to finish

2027-04-01

Last updated by the study team

2023-08-29

Who can join

Age: 40 and older, up to 74. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 1) 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…

• 1) 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.

Where it is running

• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (enrolling)
• Yangzhou First People's Hospital — Yangzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.