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NCT04912765
Adenocarcinoma, Carcinoma
Singapore
View Trial DetailsNCT Number: NCT05336539
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.
Interested in participating?
Request Info40 year–74 year
All sexes
Observational
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
The study is expected to complete baseline examinations of 80,000 subjects within 1 year. Community members who sign informed consent forms will complete the Colorectal cancer Risk Factor Assessment Questionnaire, history collection, and colorectal cancer polymethylation test early screening at baseline. Subjects who tested positive for polygene methylation screening for colorectal cancer will undergo a fecal immunochemistry (FIT) test, a blood carcinoembryo antigen (CEA) test, and colonoscopy within 3 months. Telephone follow-up medical history was collected at 1, 2, 3, and 4 years after baseline, and telephone follow-up survival outcomes were studied at 5 years after baseline. During the follow-up, patients diagnosed with colorectal cancer by colonoscopy will reach the study end point, and patients treated with polyps or adenomas found during colonoscopy will also reach the study end point.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: assessed up to 5 years
To evaluate the sensitivity, specificity, and positive/negative predictive value of polygenic methylation tests for colorectal cancer in subjects
Time frame: assessed up to 5 years
To verify the effectiveness and clinical value of this detection method in the diagnosis of colorectal cancer in yangzhou community population.
Contact information is provided by the study sponsor or research team.
Singlera Genomics Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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