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Trial Title:
A Prospective Cohort Study on Colorectal Cancer Screening in Community Population
NCT ID:
NCT05485077
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
ctDNA methylation
Community population screening
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This study will validate the real world results of polygene methylation detection in
colorectal cancer in a large prospective community cohort. In this study, questionnaire
survey and polygene methylation detection technology of colorectal cancer were used as
preliminary screening methods, and colonoscopy was used as 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.
Detailed description:
1. The informed consent signed by shougang Community will be completed in the baseline
period: Colorectal cancer risk factors assessment questionnaire, medical history
collection, fecal immunochemical (FIT), carcinoembryonic antigen (CEA) blood test
and blood bowel cancer gene methylation detection, for colorectal cancer gene
methylation detection results more positive subjects and the result of the negative
part of the subjects (n = 500), within 3 months after receiving the results complete
colonoscopy.
2. Follow-up at 1, 2, 3, 4, and 5 years after baseline included: ① Central follow-up at
1, 3, and 5 years: history collection, colonoscopy, FIT test, and CEA examination; ②
Telephone follow-up at the 2nd and 4th years: medical history was collected; (3)
Survival outcome registration was performed in the fifth year; Follow-up history was
collected at 1, 2, 3, 4, and 5 years after completion of baseline, and survival
outcomes were registered at 5 years.
3. During the follow-up, the subjects were confirmed to be diagnosed with colorectal
cancer by evaluation (colorectal cancer was diagnosed by colonoscopy), and the
subjects who were treated after polyps or adenomas were found during colonoscopy
also reached the study endpoint.
Criteria for eligibility:
Study pop:
18000 samples from Shougang community
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Chronological age ≥40 years;
2. Full capacity for action;
3. After enrollment, the participants were able to complete the Colorectal Cancer Risk
Factor Assessment Questionnaire and the annual follow-up interviews;
4. In the course of the study, the information related to tumor diagnosis in other
hospitals can be timely fed back to the researchers;
Exclusion Criteria:
1. History of colorectal cancer and other malignant tumors;
2. Previous colorectal resection;
3. undergoing any cancer-related treatment;
4. Patients who have received major surgical treatment such as blood transfusion or
transplantation within 3 months;
5. Participate in other interventional clinical investigators within 3 months;
6. Pregnant or lactating women;
7. Have autoimmune disease, hereditary disease, mental illness/disability, etc
8. Poor compliance, unable to complete the study.
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking University Shougang Hospital
Address:
City:
Beijing
Zip:
100144
Country:
China
Status:
Recruiting
Contact:
Last name:
Jin Gu, Doctor
Phone:
010-57830127
Email:
yuanping_632@163.com
Contact backup:
Last name:
Ping Yuan
Phone:
15210919487
Start date:
July 9, 2022
Completion date:
July 9, 2028
Lead sponsor:
Agency:
Singlera Genomics Inc.
Agency class:
Industry
Collaborator:
Agency:
Peking University Shougang Hospital
Agency class:
Other
Source:
Singlera Genomics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05485077