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

April 16, 2018 updated by: Genomictree, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

634

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genomictree, Inc.

Collaborators

Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2016

Primary Completion (Actual)

March 18, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

May 7, 2017

First Submitted That Met QC Criteria

May 7, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2016-0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on EarlyTect Colon Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe