Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China

Completed

• Conditions: Colorectal Cancer; Advanced Adenoma; Adenoma; Adenomatous Polyps
• Interventions: Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear; Diagnostic Test: FIT; Procedure: Colonoscopy

• Registration Number: NCT04287335
• Lead Sponsor: Zhejiang University

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.

Detailed Description

The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference.

Study Timeline

• Study Start: 2018-09-18
• Primary Completion: 2019-12-08
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Study Completion: 2020-09-13
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4758

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High risk CRC screening group	Multitarget stool FIT-DNA test - ColoClear	Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer
High risk CRC screening group	Colonoscopy	Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer
CRC group	Multitarget stool FIT-DNA test - ColoClear	Retrospective enrollment of subjects with confirmed colorectal cancer
CRC group	FIT	Retrospective enrollment of subjects with confirmed colorectal cancer
High risk CRC screening group	FIT	Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer
CRC group	Colonoscopy	Retrospective enrollment of subjects with confirmed colorectal cancer

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy	Through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
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	A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The ColoClear and FIT test were performed on the same stool sample.

Trial Locations

Locations (8)

Shanxi Provincial People's Hospital; 🇨🇳 Taiyuan, Shanxi, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China

The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China