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Completed

NCT Number: NCT04304131

Colorectal Cancer Screening Using Stool DNA-based SDC2 Methylation Test

A study of colorectal cancer screening using stool DNA-based SDC2 methylation test

Completed

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Key information

Conditions

Colorectal Cancer Colon Polyp Colonic Diseases Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Healthy Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Busan Hangun Hospital, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who agreed the clinical trial and signed informed consent
  • High risk patient for colorectal cancer (family history of colorectal cancer, history of adenomatous polyp excision, inflammatory bowel disease > 15 years, or history of hereditary colorectal cancer)
  • Patient who scheduled to receive colonoscopy
  • Stool > 20g before bowel preparation for colonoscopy

Exclusion criteria

  • No high risk patient under 60 years
  • History of colorectal cancer
  • Stool < 20g or sample after bowel preparation
  • Diarrhea or liquid stool which cannot be evaluated
  • Patient who is judged as not suitable for clinical trial including a psychiatric disorder by a physician

Treatment and study plan

Earlytect Colon Cancer

Diagnostic Test

A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer

Primary outcomes

  1. SDC2 methylation in stool DNA

    Time frame: 1 year

    positive ratio of SDC2 methylation

  2. sensitivity and specificity of EarlyTect

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Kyung Hee University Hospital at Gangdong

Other

Collaborators

  • Genomictree, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2020
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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