Status:
COMPLETED
A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Gongli Hospital of Shanghai Pudong New Area
Conditions:
Colorectal Cancer
Colorectal Neoplasm
Eligibility:
All Genders
45-75 years
Brief Summary
to determine screening value of stool-based SDC2 DNA methylation test for advanced colorectal neoplasia in the asymptomatic Chinese community population.
Detailed Description
In China, colorectal cancer (CRC) remains to be the leading cancer of the digestive system. According to nationwide cancer statistics using population-based cancer registry data in China, age-standard...
Eligibility Criteria
Inclusion
- Asymptomatic screening individual (no alarm features predicting colorectal cancer including hematochezia, melena, anemia of unknown cause, weight loss, abdominal mass, a positive result of digital rectal examination)
- Age between 45 to 75 years old, the gender is not limited
- Willing to participate and sign informed consent
Exclusion
- Patients with contraindications for bowel preparation or colonoscopy
- Patients with known colorectal adenoma or serrated lesions
- History of colonoscopy within 5 years or polypectomy
- Patients with inflammatory bowel disease
- History of CRC and patients clinically highly suspected with colorectal cancer
- History of hereditary CRC syndrome (including polyposis)
- Patients taking anticoagulants such as aspirin and warfarin within 7 days, or who have coagulopathy
- Pregnancy, or severe organ insufficiency (heart, lung, or kidney et al)
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2022
Estimated Enrollment :
12106 Patients enrolled
Trial Details
Trial ID
NCT04786704
Start Date
March 22 2021
End Date
June 25 2022
Last Update
June 28 2022
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433