Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA.
Shicheng Guo, Dinh Diep, Nongluk Plongthongkum...
https://pubmed.ncbi.nlm.nih.gov/28263317Actively Recruiting
Age: 40Years - 74Years
All Genders
Healthy Volunteers
ID05336539
Community Screening Study Using Polygene Methylation Detection for Colorectal Cancer in Yangzhou
Led by Singlera Genomics Inc. · Updated on 2023-08-29
80000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Singlera Genomics Inc.
Lead Sponsor
N
Northern Jiangsu People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a large community-based observational study in Yangzhou to assess the effectiveness of a polygene methylation test in screening for colorectal cancer. This study aims to evaluate how well this test detects colorectal cancer and precancerous lesions in real-world settings by enrolling 80,000 permanent residents aged 40 to 74 years. The study will last five years and is jointly developed by Northern Jiangsu People's Hospital and Shanghai Kunyuan Biological Technology Co., LTD. At the start, participants will complete a colorectal cancer risk questionnaire and provide samples for the polygene methylation test. Those with positive test results will undergo further testing including a fecal immunochemistry test, blood carcinoembryonic antigen test, and colonoscopy within three months. These follow-up tests help confirm the presence of colorectal cancer or precancerous lesions. Participants will be followed by phone at 1, 2, 3, 4, and 5 years after the initial screening to collect medical history and survival outcomes. The study will use colonoscopy and pathology results to confirm diagnoses. Researchers will assess outcomes such as the sensitivity, specificity, and detection rates of the screening methods, with study endpoints reached when colorectal cancer or related lesions are diagnosed or treated.
CONDITIONS
Brief Title
A Community Population Screening Cohort Study Based on Polygene Methylation Detection for Colorectal Cancer in Yangzhou
Who Can Participate
Age: 40Years - 74Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Permanent resident population of Yangzhou
- Age between 40 and 74 years, including birthday cutoffs
- Full capacity to participate
- Willing to complete colorectal cancer risk questionnaire and accept telephone follow-up
- Agree to provide timely tumor diagnosis information during study
- Able and willing to sign informed consent
You will not qualify if you...
- History of colorectal cancer or other malignant tumors
- Previous colorectal surgery
- Currently receiving any cancer-related treatment
- Major surgery, blood transfusion, or transplantation within last 3 months
- Participation in other interventional clinical studies within last 3 months
- Pregnant or breastfeeding women
- Autoimmune diseases, genetic diseases, mental illness or disabilities, or other conditions deemed unsuitable by researchers
- Poor compliance or inability to complete the study as judged by researchers
AI-Screening
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Your Study Journey
Screening
Duration - Up to 1 year
Participants are screened for eligibility to participate in the trial.
1 baseline visit (in-person) for questionnaire, history collection, and polygene methylation test
Diagnostic Evaluation
Duration - Within 3 months after baseline screening
Participants who test positive for the polygene methylation screening undergo further diagnostic evaluations including fecal immunochemistry (FIT) testing, blood carcinoembryonic antigen (CEA) testing, and colonoscopy.
Up to 3 visits (in-person) for FIT test, blood test, and colonoscopy
Long-term Monitoring
Duration - 5 years after baseline
Participants are followed up by telephone to collect medical history annually for 4 years and survival outcomes at 5 years after baseline.
Telephone follow-up at years 1, 2, 3, 4, and 5
Trial Site Locations
Total: 2 locations
1
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China, 201299
Actively Recruiting
2
Yangzhou First People's Hospital
Yangzhou, Jiangsu, China, 225007
Actively Recruiting
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Research Team
L
Liu Jun, Master
L
Liu Rui, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Colorectal cancer screening using a multi-locus blood-based assay targeting circulating tumor DNA methylation: a cross-sectional study in an average-risk population.
Baohua Wang, Yunzhi Zhang, Jun Liu...
https://pubmed.ncbi.nlm.nih.gov/39604913