Status:
COMPLETED
Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
New Horizon Health Technology Co., Ltd
Beijing Mingze Technology Co., Ltd.
Conditions:
Colorectal Cancer
Adenomatous Polyps
Eligibility:
All Genders
40-74 years
Brief Summary
The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced ne...
Detailed Description
The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to col...
Eligibility Criteria
Inclusion
- Willing to provide written consent
- Able to provide stool sample
- For high risk CRC screening group:
- Scheduled for colonoscopy voluntarily or by physician prescription
- CRC high risk profile as defined below:
- History of FIT positivity
- Family history of CRC
- Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress
- For CRC group:
- Confirmed CRC patients
- No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures
Exclusion
- Unwilling to provide stool samples
- FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis
- Prior history of colonoscopy within the past 5 years and removal of lesions
- History of CRC
- other conditions deemed not suited for the study by investigators
Key Trial Info
Start Date :
September 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 13 2020
Estimated Enrollment :
4758 Patients enrolled
Trial Details
Trial ID
NCT04287335
Start Date
September 18 2018
End Date
September 13 2020
Last Update
December 8 2020
Active Locations (8)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
2
Hubei Cancer Hospital
Wuhan, Hubei, China
3
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
4
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China