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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colorectal Adenomatous Polyp
• Intervention / Treatment: Diagnostic test: Stool DNA test

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Hongzhi Zou, MD, PhD; Phone Number: 86-020-82510982; Email: zouhongzhi@creativebio.cn
• Study Contact Backup: Name: Yan Qi, PhD; Phone Number: 86-020-82510982; Email: qiyan@creativebio.cn

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • The Sixth Affiliated Hospital, Sun Yet-sen University
  • Shanghai, China
    • Recruiting
    • Changhai Hospital
    • Contact: Enda Yu, MBBS
  • Tianjin, China
    • Recruiting
    • Tianjin Nankai Hospital
    • Contact: Ximo Wang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants at high risk of developing colorectal cancer.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mutiple screening test group	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.; Other Names: Blood mRNA test; FIT Assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer.	6 months

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Changhai Hospital; Tianjin Nankai Hospital
• Investigators: Principal Investigator: Hongzhi Zou, MD, PhD, The Sixth Affiliated Hospital, Sun Yet-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 20, 2018
• First Submitted That Met QC Criteria: January 20, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal cancer screening; Stool DNA test; Blood mRNA test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Adenoma; Colorectal Neoplasms; Polyps; Adenomatous Polyps
• Other Study ID Numbers: SC2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No