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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colorectal Adenomatous Polyp
• Colorectal Cancer
• Colorectal Neoplasms
• Polyps

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