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

Study Overview
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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.

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

Conditions
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Colorectal Cancer, Adenomatous Polyps, Adenoma, Advanced Adenoma

Intervention / Treatment
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* Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear
* Diagnostic Test: FIT
* Procedure: Colonoscopy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk CRC screening group<br>Prospective enrollment of subjects with pre-defined high risk factors for developing colorectal cancer | Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear<br>* Multitarget stool FIT-DNA test<br>Diagnostic Test: FIT<br>* fecal immunochemical test<br>Procedure: Colonoscopy<br>* diagnostic colonoscopy<br>|
| CRC group<br>Retrospective enrollment of subjects with confirmed colorectal cancer | Diagnostic Test: Multitarget stool FIT-DNA test - ColoClear<br>* Multitarget stool FIT-DNA test<br>Diagnostic Test: FIT<br>* fecal immunochemical test<br>Procedure: Colonoscopy<br>* diagnostic colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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