Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection

Study Overview
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Brief Summary
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Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.

Detailed Description
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The purpose of this study is to validate the clinical performance of EarlyTect Colon Cancer test which is measuring Syndecan 2 methylation status in stool DNA to detect CRC. Syndecan 2 (SDC2) is a newly developed methylation biomarker for colorectal cancer diagnosis. Methylation status of SDC2 gene in stool DNA is determined by methylation specific qPCR. Sensitivity and specificity will be determined by comparing Stool DNA test from healthy subjects, CRC patients, and other group including polyps and other diseases.

Official Title
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Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer

Conditions
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Polyps, Colorectal Cancer, Other Cancers, Healthy

Intervention / Treatment
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* Device: EarlyTect Colon Cancer


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: sample information is complete, including sample number, gender, family history, stage of cancer, treatment history, and other disease information the CRC patient who has not any treatment (surgery, chemotherapy, or radiation) non-CRC patient who has not received any treatment (surgery, chemotherapy, or radiation) within the last 6 months all of above conditions are satisfied, and any one of below can be applicable; 1) confirm to be CRC with colonoscopy and/or pathological examination, 2) confirm to be inflammatory or ulcerative bowel diseases or benign hyperplastic polyp, 3) confirm to be gastrointestinal or liver cancers who are not CRC, 4) schedule to receive colonoscopy and additional confirmation test for CRC with agreement to provide the test results. Exclusion criteria: any one of below can be applicable; the patient information is not complete and/or does not satisfy inclusion criteria the sample information is not complete and/or does not satisfy inclusion criteria the CRC patient who has history of colorectal cancer surgery, chemotherapy, or any other treatment non-CRC patient who received any chemotherapy within the last 6 months the patient who has limited ability or are vulnerable to accept clinical trial agreement the patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician

Ages Eligible for Study
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Minimum Age: 30 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal (CRC)<br>stage I-IV CRC subjects | Device: EarlyTect Colon Cancer<br>* SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit<br>|
| Polyps<br>subjects with adenoma or polyps | Device: EarlyTect Colon Cancer<br>* SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit<br>|
| Other cancers<br>subjects with other cancers | Device: EarlyTect Colon Cancer<br>* SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit<br>|
| Healthy<br>subjects with no evidence of CRC | Device: EarlyTect Colon Cancer<br>* SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer | Sensitivity and specificity of EarlyTect Colon Cancer to detect colorectal cancer (sensitivity: the ratio of positive cases in all CRC cases, specificity: the ratio of negative cases in all healthy controls) | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive ratio of SDC2 methylation in polyps | the ratio of SDC2 methylation positive in polyps | 1.5 years | 
| Positive ratio of SDC2 methylation in other cancers | the ratio of SDC2 methylation positive in other cancers | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Syndecan 2, Methylation biomarker, Colorectal cancer, EarlyTect Colon Cancer test