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

NCT ID: NCT04287335

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4758 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-18

Study Completion Date

2020-09-13

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Adenomatous Polyps Adenoma Advanced Adenoma

Keywords

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Cancer Colorectal Cancer Colorectal Neoplasms Adenomatous Polyps Adenoma Advanced adenoma Gastrointestinal Diseases Colonic Diseases Neoplasms Digestive System Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Intestinal Diseases Rectal Diseases Glandular and Epithelial Neoplasms by Histologic Type

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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High risk CRC screening group

Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer

Multitarget stool FIT-DNA test - ColoClear

Intervention Type DIAGNOSTIC_TEST

Multitarget stool FIT-DNA test

FIT

Intervention Type DIAGNOSTIC_TEST

fecal immunochemical test

Colonoscopy

Intervention Type PROCEDURE

diagnostic colonoscopy

CRC group

Retrospective enrollment of subjects with confirmed colorectal cancer

Multitarget stool FIT-DNA test - ColoClear

Intervention Type DIAGNOSTIC_TEST

Multitarget stool FIT-DNA test

FIT

Intervention Type DIAGNOSTIC_TEST

fecal immunochemical test

Colonoscopy

Intervention Type PROCEDURE

diagnostic colonoscopy

Interventions

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Multitarget stool FIT-DNA test - ColoClear

Multitarget stool FIT-DNA test

Intervention Type DIAGNOSTIC_TEST

FIT

fecal immunochemical test

Intervention Type DIAGNOSTIC_TEST

Colonoscopy

diagnostic colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New Horizon Health Technology Co., Ltd

UNKNOWN

Sponsor Role collaborator

Beijing Mingze Technology Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Ding Ke-Feng

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kefeng Ding, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Site Status

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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CLEAR-C 2018

Identifier Type: -

Identifier Source: org_study_id