NCT05336539Recruiting
A Community Population Screening Cohort Study Based on Polygene Methylation Detection for Colorectal Cancer in Yangzhou
Source: ClinicalTrials.gov · Last updated 29 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80000 (estimated)
- First submitted
- 13 Apr 2022
- Start date
- 1 Apr 2022
- Primary completion date
- Apr 2027
- Lead sponsor
- Singlera Genomics Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT05336539
What you commit to
- Study type: Observational
- Planned participants: 80000
- From 1 Apr 2022 to the primary completion date, Apr 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 74 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northern Jiangsu People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Recruiting |
| Yangzhou First People's Hospital Coordinator of this site? Confirm its status | Yangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.