Clinical trial NCT03146520: Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
Official title: Clinical Study for the Validation of Real Time qPCR for SDC2 Methylation in Stool DNA for Early Detection of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Polyps
Other Cancers
Healthy
Keywords: Syndecan 2
Methylation biomarker
Colorectal cancer
EarlyTect Colon Cancer test
Lead sponsor: Genomictree, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
First posted: 2017-05-10
Enrollment: 634
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have colorectal cancer or pre-malignancy or benign polyp or other solid tumor, or healthy normal subjects, and confirmed by colonoscopy or pathological examination.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical performance of EarlyTect Colon Cancer to detect colorectal cancer
timeFrame: 1.5 years
Secondary outcomes:
measure: Positive ratio of SDC2 methylation in polyps
timeFrame: 1.5 years
measure: Positive ratio of SDC2 methylation in other cancers
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: 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.
citation: Han YD, Oh TJ, Chung TH, Jang HW, Kim YN, An S, Kim NK. Early detection of colorectal cancer based on presence of methylated syndecan-2 (SDC2) in stool DNA. Clin Epigenetics. 2019 Mar 15;11(1):51. doi: 10.1186/s13148-019-0642-0.