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NCT03411707 Clinical Trial

Multiple Screening Methods for the Detection of Chinese Colorectal Advanced Adenomatous Polyps and Cancer

Colorectal Cancer Clinical Trial

Official title:
A Multicenter Clinical Trial for the Comparison Among Fecal Immunochemical Test, Stool DNA Test and Blood mRNA Test in Chinese Colorectal Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03411707
Other study ID # SC2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 19, 2018
Est. completion date June 2023

Study information
Verified date May 2022
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact Hongzhi Zou, MD, PhD
Phone 86-020-82510982
Email zouhongzhi@creativebio.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria: 1. Subjects received screening questionnaire and had been defined as high risk. 2. Subjects haven't received any treatment under colonoscopy within 10 years. Exclusion Criteria: 1. Subjects are under the usage of specific drugs which might affect the screening test. 2. Subjects had the contraindication for colonoscopy.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Stool DNA test
Stool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood.

Locations
Country Name City State
China The Sixth Affiliated Hospital, Sun Yet-sen University Guangzhou
China Changhai Hospital Shanghai
China Tianjin Nankai Hospital Tianjin

Sponsors (3)
Lead Sponsor Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University Changhai Hospital, Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer. 6 months
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