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

Colorectal Cancer Clinical Trial

— CLEAR-C  

Official title:

Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287335
• Other study ID #: CLEAR-C 2018
• Status: Completed
• Start date: September 18, 2018
• Est. completion date: September 13, 2020

Study information

• Verified date: December 2020
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4758
• Est. completion date: September 13, 2020
• Est. primary completion date: December 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Advanced Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Multitarget stool FIT-DNA test - ColoClear
Multitarget stool FIT-DNA test
• FIT
fecal immunochemical test

Procedure:
• Colonoscopy
diagnostic colonoscopy

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (3)

Lead Sponsor	Collaborator
Zhejiang University	Beijing Mingze Technology Co., Ltd., New Horizon Health Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy	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.	Through study completion, an average of 1 year
Secondary	Sensitivity of the ColoClear screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC	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.	Through study completion, an average of 1 year