Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
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ClinicalTrials.gov Identifier: NCT03146520 |
Recruitment Status :
Completed
First Posted : May 10, 2017
Last Update Posted : April 18, 2018
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Condition or disease | Intervention/treatment |
---|---|
Colorectal Cancer Polyps Other Cancers Healthy | Device: EarlyTect Colon Cancer |
Study Type : | Observational |
Actual Enrollment : | 634 participants |
Observational Model: | Case-Control |
Time Perspective: | Other |
Official Title: | Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer |
Actual Study Start Date : | December 13, 2016 |
Actual Primary Completion Date : | March 18, 2018 |
Actual Study Completion Date : | March 30, 2018 |

Group/Cohort | Intervention/treatment |
---|---|
Colorectal (CRC)
stage I-IV CRC subjects
|
Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit |
Polyps
subjects with adenoma or polyps
|
Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit |
Other cancers
subjects with other cancers
|
Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit |
Healthy
subjects with no evidence of CRC
|
Device: EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit |
- Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer [ Time Frame: 1.5 years ]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)
- Positive ratio of SDC2 methylation in polyps [ Time Frame: 1.5 years ]the ratio of SDC2 methylation positive in polyps
- Positive ratio of SDC2 methylation in other cancers [ Time Frame: 1.5 years ]the ratio of SDC2 methylation positive in other cancers

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146520
Korea, Republic of | |
Severance Hospital | |
Seoul, Korea, Republic of, 03722 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Genomictree, Inc. |
ClinicalTrials.gov Identifier: | NCT03146520 |
Other Study ID Numbers: |
1-2016-0068 |
First Posted: | May 10, 2017 Key Record Dates |
Last Update Posted: | April 18, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Syndecan 2 Methylation biomarker Colorectal cancer EarlyTect Colon Cancer test |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |