A Prospective Cohort Study on Colorectal Cancer Screening in Community Population
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorSinglera Genomics Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Chronological age ≥40 years;
Full capacity for action;
After enrollment, the participants were able to complete the Colorectal Cancer Risk Factor Assessment Questionnaire and the annual follow-up interviews;
In the course of the study, the information related to tumor diagnosis in other hospitals can be timely fed back to the researchers;
Disqualifiers
History of colorectal cancer and other malignant tumors;
Previous colorectal resection;
undergoing any cancer-related treatment;
Patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months;
Trial population
18000 samples from Shougang community
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
18,000 Participants
are grouped into 2 trial groupsGroup A: Positive group
Group B: Negative group
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of polygene methylation detection in colorectal cancer
To investigate the sensitivity and specificity of polygene methylation in the diagnosis of colorectal cancer in community population, and to evaluate its value as an auxiliary diagnosis
Time frame
assessed up to 72 months2
Negative predictive value and positive predictive value of polygene methylation in colorectal cancer
To obtain the positive predictive value and negative predictive value of polygene methylation test for colorectal cancer early screening, and compare with FIT test and blood CEA test.
Time frame
assessed up to 72 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Singlera Genomics Inc.
Lead sponsor
Peking University Shougang Hospital
Collaborator
Source ClinicalTrials.gov