A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer

March 31, 2025 updated by: Genomictree, Inc.

A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® CRC Test for the Early Detection of Colorectal Cancer in the Stool DNA From High-risk Group

The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® CRC test for detecting CRC, using colonoscopy as the reference method.

The secondary objective is to compare the clinical performance of EarlyTect® CRC test with a commercially available Fecal Immunochemical Test (FIT), with respect to CRC. By histopathological examination, lesions identified during colonoscopy will be confirmed as malignant or precancerous by histological examination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multicenter, single-blind, prospective clinical trial is being conducted to evaluate the clinical performance of EarlyTect® CRC test. Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC who are eligible for inclusion criteria will be asked to collect a stool sample and EarlyTect® CRC and FIT tests will be performed. For confirmation of the diagnosis and tumor staging, representative histopathology slides obtained from curative surgery and representative histopathology slides from tissue biopsied or excised during colonoscopy may be retrieved and examined by the central pathology laboratory. Methylation status of SDC2 in stool DNA is measured by a highly accurate and sensitive real time PCR that employs Linear Target Enrichment (LTE) and quantitative Methylation-Specific PCR (qMSP)(LTE-qMSP).

Study Type

Observational

Enrollment (Actual)

2358

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC

Description

Inclusion Criteria:

Subjects enrolled into the study must meet the following criteria:

  • Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening
  • Adults aged ≥ 40 years
  • Subjects who are at high-risk (Asia Pacific Colorectal Screening (APCS) Score: 4.0~7.0) of developing CRC
  • Subjects who are able and willing to undergo colonoscopy screening within 12 months of consent among individuals who reserved a visit in the division of gastroenterology or health check-up.

Exclusion Criteria:

Subjects will be excluded from enrolling into the study if any of the following criteria are met:

  • Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening
  • Adults aged < 40 years
  • Subjects who are not at high-risk (APCS Score ≤ 3.0) of developing CRC
  • Subjects who will not undergo colonoscopy screening within 12 months of consent
  • Subjects who have had a positive FIT or fecal occult blood test within the previous 2 weeks
  • Colorectal cancer patients who did not underwent curative treatment
  • Subjects who have had a prior history of colorectal resection
  • Subjects who have had overt rectal bleeding or melena within the previous 2 weeks
  • Subjects who have a family history or a prior history of hereditary CRC or colorectal neoplasm: Lynch syndrome (HNPCC), familial adenomatous polyposis, MUTYH-associated polyposis, Juvenile polyposis syndrome, Peutz-Jeghers syndrome, and serrated polyposis syndrome, etc.
  • Subjects who have inflammatory bowel diseases including Crohn's disease, ulcerative colitis or Behcet disease
  • Subjects who participated in any "interventional" clinical study within the previous 30 days
  • Subject has any condition which, in the opinion of the medical staff should preclude participation in the study

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC aged ≥40
Device: EarlyTect® CRC test
A highly accurate and sensitive real time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE/qMSP) for measuring SDC2 methylation in stool DNA to detect CRC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC.
Time Frame: 18 months

The reference method is the colonoscopy, and lesions will be assessed histopathologically.

EarlyTect® CRC test includes a measurement of SDC2 methylation and COL2A1 as a DNA control. SDC2 methylation in stool DNA will be assessed quantitatively by LTE/qMSP. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100*(positive SDC2 methylation test/positive colonoscopy), Specificity = 100*(negative SDC2 methylation test/negative colonoscopy).
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of EarlyTect® CRC for detecting advanced colorectal adenoma (Adenomas ≥1.0 cm, villous adenomas or high-grade dysplasia)
Time Frame: 18 months

Sensitivity for detecting adenomas ≥1.0 cm

  • Sensitivity of EarlyTect® CRC for detecting villous adenomas
  • Sensitivity of EarlyTect® CRC for detecting high-grade dysplasia
18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal neoplasm
Time Frame: 18 months
Sensitivity for detecting adenomas ≥1.0 cm
18 months
Sensitivity of EarlyTect® CRC for detecting non-advanced adenomas
Time Frame: 18 months
Sensitivity for detecting non-adenomas <1.0 cm
18 months
Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC
Time Frame: 18 months
Sensitivity and specificity of combined FIT and EarlyTect® CRC tests in detecting CRC
18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions
Time Frame: 18 months
Sensitivity of EarlyTect® CRC for detecting advanced colorectal serrated lesions
18 months
Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group
Time Frame: 18 months
Clinical specificity of EarlyTect® CRC when patients with non-advanced adenomas and non-advanced colorectal serrated lesions are included in control group
18 months
Clinical sensitivity of the EarlyTect® CRC for detecting Tis
Time Frame: 18 months
Clinical sensitivity of the EarlyTect® CRC for detecting colorectal cancer with Tis
18 months

Collaborators and Investigators

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

Sponsor

Genomictree, Inc.

Collaborators

Samsung Medical Center
Pusan National University Hospital
Asan Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Gangnam Severance Hospital
Kangbuk Samsung Hospital
Severance Hospital
Keimyung University Dongsan Medical Center
Kyung Hee University Hospital at Gangdong
Soon Chun Hyang University
Wonju Severance Christian Hospital
Kyung Hee University Hospital
The Catholic Univ. of Korea Bucheon ST. Mary's 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)

February 10, 2022

Primary Completion (Actual)

May 23, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEXT-CRC

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

product manufactured in and exported from the U.S.

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.

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