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

NCT05255588 | Completed

• 1 other identifier: NEXT-CRC
• Study Type: observational
• Target: 2,358
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Colorectal cancer; SDC2; Methylation biomarker; EarlyTect® CRC test; Stool

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the EarlyTect® CRC test for detecting CRC compared to the colonoscopy, both in terms of detecting CRC.

  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 Outcomes (7)

• Sensitivity of EarlyTect® CRC for detecting advanced colorectal adenoma (Adenomas ≥1.0 cm, villous adenomas or high-grade dysplasia)

  18 months

• Sensitivity of EarlyTect® CRC for detecting advanced colorectal neoplasm

  18 months

• Sensitivity of EarlyTect® CRC for detecting non-advanced adenomas

  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

  18 months

Study Arms (1)

Cohort

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

Device: EarlyTect® CRC test

Interventions

EarlyTect® CRC test 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.

Cohort

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

Location

Related Publications (2)

• 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.

  PMID: 29225717 BACKGROUND

• 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: 30876480 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Residual stool samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subjects, using the subject ID as the only tracking information. Specimens will be stored at Genomictree and may be used for future research.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 24, 2022
• Study Start: February 10, 2022
• Primary Completion: May 23, 2024
• Study Completion: August 30, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)