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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146520
• Other study ID #: 1-2016-0068
• Status: Completed
• First received: May 7, 2017
• Last updated: April 16, 2018
• Start date: December 13, 2016
• Est. completion date: March 30, 2018

Study information

• Verified date: April 2018
• Source: Genomictree, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: March 30, 2018
• Est. primary completion date: March 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Healthy
• Other Cancers
• Polyps

Intervention

Device:
• EarlyTect Colon Cancer
SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Genomictree, Inc.	Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Oh T, Kim N, Moon Y, Kim MS, Hoehn BD, Park CH, Kim TS, Kim NK, Chung HC, An S. Genome-wide identification and validation of a novel methylation biomarker, SDC2, for blood-based detection of colorectal cancer. J Mol Diagn. 2013 Jul;15(4):498-507. doi: 10.1016/j.jmoldx.2013.03.004. Epub 2013 Jun 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Positive ratio of SDC2 methylation in polyps	the ratio of SDC2 methylation positive in polyps	1.5 years
Secondary	Positive ratio of SDC2 methylation in other cancers	the ratio of SDC2 methylation positive in other cancers	1.5 years