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

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

634 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-13

Study Completion Date

2018-03-30

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.

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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.

Conditions

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Colorectal Cancer Polyps Other Cancers Healthy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

* 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.

* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes