Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
CLEAR-C
Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients
1 other identifier
observational
4,758
1 country
8
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 neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2019
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2020
CompletedDecember 8, 2020
December 1, 2020
1.2 years
February 20, 2020
December 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, plus a hemoglobin immunoassay. A logistic-regression algorithm incorporating all the above parameters was deployed to compute a single composite score, with values of 165 or more considered to be positive. The tests were processed independently of colonoscopy procedure.
Through study completion, an average of 1 year
Secondary Outcomes (1)
Sensitivity of the ColoClear screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC
Through study completion, an average of 1 year
Study Arms (2)
High risk CRC screening group
Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer
CRC group
Retrospective enrollment of subjects with confirmed colorectal cancer
Interventions
Multitarget stool FIT-DNA test
Eligibility Criteria
Subjects with high risk of developing CRC and patients with confirmed CRC
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Universitylead
- New Horizon Health Technology Co., Ltdcollaborator
- Beijing Mingze Technology Co., Ltd.collaborator
Study Sites (8)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000, China
Biospecimen
stool sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kefeng Ding, MD
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 27, 2020
Study Start
September 18, 2018
Primary Completion
December 8, 2019
Study Completion
September 13, 2020
Last Updated
December 8, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share