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

NCT ID: NCT05255588

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2358 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2024-08-30

Brief Summary

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.

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).

Conditions

Colorectal Cancer; Advanced Colorectal Neoplasm; Advanced Adenomas; Non-neoplastic Polyps; Non-advanced Adenomas

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort

Subjects who are at high-risk (Asia Pacific Colorectal Screening Score ≥4.0) of developing CRC aged ≥40

EarlyTect® CRC test

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soon Chun Hyang University

OTHER

Sponsor Role: collaborator

Gangnam Severance Hospital

OTHER

Sponsor Role: collaborator

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role: collaborator

Kangbuk Samsung Hospital

OTHER

Sponsor Role: collaborator

Kyung Hee University Hospital

OTHER

Sponsor Role: collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: collaborator

Korea University Anam Hospital

OTHER

Sponsor Role: collaborator

Pusan National University Hospital

OTHER

Sponsor Role: collaborator

The Catholic Univ. of Korea Bucheon ST. Mary's Hospital

UNKNOWN

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: collaborator

Wonju Severance Christian Hospital

OTHER

Sponsor Role: collaborator

Severance Hospital

OTHER

Sponsor Role: collaborator

Genomictree, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Soon Chun Hyang University Hospital Seoul

Seoul, , South Korea

Countries

South Korea

References

Oh TJ, Oh HI, Seo YY, Jeong D, Kim C, Kang HW, Han YD, Chung HC, Kim NK, An S. Feasibility of quantifying SDC2 methylation in stool DNA for early detection of colorectal cancer. Clin Epigenetics. 2017 Dec 4;9:126. doi: 10.1186/s13148-017-0426-3. eCollection 2017.

Reference Type: BACKGROUND

PMID: 29225717 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30876480 (View on PubMed)

Other Identifiers

NEXT-CRC

Identifier Type: -

Identifier Source: org_study_id