Multiple Screening Methods for the Detection of Chinese Colorectal Advanced Adenomatous Polyps and Cancer
A Multicenter Clinical Trial for the Comparison Among Fecal Immunochemical Test, Stool DNA Test and Blood mRNA Test in Chinese Colorectal Cancer Screening
1 other identifier
observational
1,200
1 country
3
Brief Summary
The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination. The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2018
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedStudy Start
First participant enrolled
March 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMay 6, 2022
May 1, 2022
5.2 years
January 20, 2018
May 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer.
6 months
Study Arms (1)
Mutiple screening test group
Interventions
Stool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood.
Eligibility Criteria
Participants at high risk of developing colorectal cancer.
You may qualify if:
- Subjects received screening questionnaire and had been defined as high risk.
- Subjects haven't received any treatment under colonoscopy within 10 years.
You may not qualify if:
- Subjects are under the usage of specific drugs which might affect the screening test.
- Subjects had the contraindication for colonoscopy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen Universitylead
- Changhai Hospitalcollaborator
- Tianjin Nankai Hospitalcollaborator
Study Sites (3)
The Sixth Affiliated Hospital, Sun Yet-sen University
Guangzhou, China
Changhai Hospital
Shanghai, China
Tianjin Nankai Hospital
Tianjin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongzhi Zou, MD, PhD
The Sixth Affiliated Hospital, Sun Yet-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 20, 2018
First Posted
January 26, 2018
Study Start
March 19, 2018
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
May 6, 2022
Record last verified: 2022-05