NCT05255588Completed
A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer
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
Source: ClinicalTrials.gov · Last updated 3 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2358 (actual)
- First submitted
- 16 Feb 2022
- Start date
- 10 Feb 2022
- Primary completion date
- 23 May 2024
- Lead sponsor
- Genomictree, Inc.
- Diseases
- Colorectal cancer
- NCT number
- NCT05255588
What you commit to
- Study type: Observational
- Participants enrolled: 2358
- From 10 Feb 2022 to the primary completion date, 23 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening
- Subjects who have had a positive FIT or fecal occult blood test within the previous 2 weeks
- 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 participated in any "interventional" clinical study within the previous 30 days
Other illness
- Colorectal cancer patients who did not underwent curative treatment
- Subjects who have inflammatory bowel diseases including Crohn's disease, ulcerative colitis or Behcet disease
- Subject has any condition which, in the opinion of the medical staff should preclude participation in the study
Age
- Adults aged \< 40 years
Other
- Subjects will be excluded from enrolling into the study if any of the following criteria are met:
- 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
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soon Chun Hyang University Hospital Seoul Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.