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NCT03728348 · ClinicalTrials.gov registry record
An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now
A clinical trial, sponsored by Exact Sciences Corporation.
- Completed
- Registry status
- 983
- Enrollment target
NCT03728348: Completed study, sponsored by Exact Sciences Corporation.
NCT03728348 is a clinical trial that has completed, run by Exact Sciences Corporation. The registered enrollment target is 983 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03728348 has completed, sponsored by Exact Sciences Corporation.
- COMPLETED
- Registry status
- 983 participants
- Enrollment target
Study Summary
The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.
Primary Outcome
An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of
Interventions
- PROCEDURE Colonoscopy
- DIAGNOSTIC_TEST mt-sDNA screening test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 983 participants |
| Start Date | 2018-11-06 |
| Est. Completion | 2019-06-18 |
What the finished NCT03728348 record still lists
NCT03728348 is an observational study that tracks outcomes without assigning an intervention. The registered 983 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Colonoscopy is the first listed.
NCT03728348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03728348 about?
NCT03728348 is a clinical study titled "An Evaluation of a Multi-target Stool DNA (Mt-sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for Development of Colorectal Cancer: Act Now". The primary objective is to confirm the specificity of a multi-target stool DNA test (mt-sDNA), Cologuard, in an average risk population, ages 45-49.
What is the current status of trial NCT03728348?
This trial is currently completed. The enrollment target is 983 participants. The study started on 2018-11-06. Estimated completion is 2019-06-18.
What interventions are being tested in trial NCT03728348?
The interventions under investigation include: Colonoscopy (PROCEDURE), mt-sDNA screening test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03728348?
This trial is sponsored by Exact Sciences Corporation, which has 30 total clinical trials registered on ClinicalTrials.gov.
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