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
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|ClinicalTrials.gov Identifier: NCT03728348|
Recruitment Status : Completed
First Posted : November 2, 2018
Results First Posted : June 4, 2021
Last Update Posted : June 4, 2021
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Diagnostic Test: mt-sDNA screening test Procedure: Colonoscopy|
|Study Type :||Observational|
|Actual Enrollment :||983 participants|
|Official Title:||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|
|Actual Study Start Date :||November 6, 2018|
|Actual Primary Completion Date :||June 18, 2019|
|Actual Study Completion Date :||June 18, 2019|
Subject aged 45-49 with Average CRC Risk
Subject aged 45-49 with average risk for development of CRC.
Diagnostic Test: mt-sDNA screening test
Stool samples will be collected by the subject for the mt-sDNA screening test.
Other Name: Cologuard
Subjects will undergo a screening colonoscopy.
- Specificity of the Multi-target Stool DNA Test in Average Risk Population, Ages 45-49 [ Time Frame: Through study completion, an average of 60 days ]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 the total amount of human DNA in each sample. Specificity =100*(multi-target stool DNA test negative/negative colonoscopy)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728348
|Principal Investigator:||Thomas Imperiale, MD||Indiana University|