Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

Study Overview
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Brief Summary
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The primary objective is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical Test(FIT) , on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population. Subjects with positive results in either test will receive colonoscopy. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Detailed Description
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A large cohort of participants will be asked to collect stool sample for either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test. Subjects who have positive results will undergo colonoscopy within 6 months. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.

Official Title
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Stool-based SDC2 DNA Methylation Test vs. Fecal Immunochemical Test on the Detection of Colorectal Advanced Adenomatous Polyps and Cancer in Chinese Population: A Multi-central Randomized Clinical Trial

Conditions
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Colorectal Cancer, Colorectal Adenomatous Polyp, Screening

Intervention / Treatment
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* Diagnostic Test: Stool-based SDC2 DNA methylation test
* Diagnostic Test: Fecal immunochemical test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is average risk for development of colorectal cancer. Subject is able and willing to undergo a screening colonoscopy within six months of enrollment. Subject is 45 to 80 years of age inclusive. Subject is able to comprehend, sign, and date the written informed consent document to participate in the study. Subject is able and willing to provide stool samples according to written instructions provided to them. Exclusion Criteria: Subject has any condition which, in the opinion of the investigator should preclude participation in the study. Subject has a history of colorectal cancer or adenoma. Subject has a history of other digestive tract cancer.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will received either Stool-based SDC2 DNA Methylation Test or Fecal Immunochemical Test.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stool-based SDC2 DNA methylation test group<br>Subjects will received the stool-based SDC2 DNA methylation test for the screening of colorectal advanced adenomatous polyps and cancer. | Diagnostic Test: Stool-based SDC2 DNA methylation test<br>* Stool-based SDC2 DNA methylation test<br>|
| Active Comparator: Fecal immunochemical test group<br>Subjects will received the fecal immunochemical test for the screening of colorectal advanced adenomatous polyps and cancer. | Diagnostic Test: Fecal immunochemical test<br>* Fecal immunochemical test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Detection Rate of Colorectal Polyps, Advanced Adenomatous Polyps and Cancer by Two Screening Methods | The stool-based SDC2 DNA methylation test CT values of 38 or less compared to beta-actin considered to be positive. Fecal immunochemical test values of more than 100 ng of hemoglobin per milliliter of buffer were considered as positive. An optical colonoscopy is used as diagnostic method. Lesions will be confirmed by histopathologic examination. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer screening, SDC2 DNA Methylation, Fecal immunochemical test