NCT03146520

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2018

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.3 years

First QC Date

May 7, 2017

Last Update Submit

April 16, 2018

Conditions

Colorectal CancerPolypsOther CancersHealthy

Keywords

Syndecan 2Methylation biomarkerColorectal cancerEarlyTect Colon Cancer test

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Positive ratio of SDC2 methylation in polyps

    1.5 years

  • Positive ratio of SDC2 methylation in other cancers

    1.5 years

Study Arms (4)

Colorectal (CRC)

stage I-IV CRC subjects

Device: EarlyTect Colon Cancer

Polyps

subjects with adenoma or polyps

Device: EarlyTect Colon Cancer

Other cancers

subjects with other cancers

Device: EarlyTect Colon Cancer

Healthy

subjects with no evidence of CRC

Device: EarlyTect Colon Cancer

Interventions

EarlyTect Colon CancerDEVICE

SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit

Colorectal (CRC)HealthyOther cancersPolyps

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 23747112BACKGROUND

  • 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.

    PMID: 30876480DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsPolyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 10, 2017

Study Start

December 13, 2016

Primary Completion

March 18, 2018

Study Completion

March 30, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)