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

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

Interventions

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.

Sponsors & Collaborators

• Soon Chun Hyang University

  collaborator OTHER

• Gangnam Severance Hospital

  collaborator OTHER

• Kyung Hee University Hospital at Gangdong

  collaborator OTHER

• Kangbuk Samsung Hospital

  collaborator OTHER

• Kyung Hee University Hospital

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Pusan National University Hospital

  collaborator OTHER

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

  collaborator UNKNOWN

• Samsung Medical Center

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Genomictree, Inc.

  lead INDUSTRY

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-10

Primary Completion

2024-05-23

Completion

2024-08-30

Countries

• South Korea

Study Locations