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Completed

NCT Number: NCT04287335

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

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.

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Key information

Conditions

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

Age range

40 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multitarget stool FIT-DNA test - ColoClear

Diagnostic Test

Multitarget stool FIT-DNA test

FIT

Diagnostic Test

fecal immunochemical test

colonoscopy

Procedure

diagnostic colonoscopy

Primary outcomes

  1. Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy

    Time frame: 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 outcomes

  1. Sensitivity of the ColoClear screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • Beijing Mingze Technology Co., Ltd.
  • New Horizon Health Technology Co., Ltd

Registry information

Official study title

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

Acronym: CLEAR-C

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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