Screening for colorectal cancer using polygene methylation detection in a community population
A Community Population Screening Cohort Study Based on Polygene Methylation Detection for Colorectal Cancer in Yangzhou
This study is testing a new way to screen for colorectal cancer using a special test on 80,000 people in Yangzhou to see how well it can find cancer and precancerous conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80000 (estimated) |
| Ages | 40 Years to 74 Years |
| Sex | All |
| Sponsor | Singlera Genomics Inc. Industry-sponsored |
| Locations | 2 sites (Yangzhou, Jiangsu and 1 other locations) |
| Trial ID | NCT05336539 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the effectiveness of polygene methylation detection for colorectal cancer screening among 80,000 permanent residents in Yangzhou. Participants will complete a colorectal cancer risk assessment questionnaire and undergo polygene methylation testing, with those testing positive referred for further validation through colonoscopy. The study will track outcomes over five years, assessing the sensitivity, specificity, and detection rates of precancerous lesions. The goal is to establish real-world effectiveness of this screening method in a large community setting.
Who should consider this trial
Good fit: Ideal candidates are permanent residents of Yangzhou aged 40 to 74 who can provide informed consent and complete follow-up assessments.
Not a fit: Patients with a history of colorectal cancer, other malignancies, or those currently receiving cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection of colorectal cancer, potentially improving patient outcomes through timely intervention.
How similar studies have performed: While the approach of using polygene methylation detection is innovative, similar studies have shown promise in enhancing colorectal cancer screening methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Yangzhou, Jiangsu and 1 other locations
- Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (Recruiting)
- Yangzhou First People's Hospital — Yangzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Liu Rui, Doctor — Singlera Genomics Inc.
- Study coordinator: Liu Jun, Master
- Email: sbyy_liujun@163.com
- Phone: 18051061318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.