ColoSense Post-Approval Study
ConditionColorectal Cancer (Diagnosis)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGeneoscopy, Inc.
About this trial
The post-approval study (PAS) described here will supplement existing data generated in the CRC-PREVENT clinical trial. The primary outcomes of this supplemental study will include: clinical sensitivity, clinical specificity, positive predictive value (PPV), and negative predictive value (NPV) of ColoSense.
Eligibility criteria
Qualifiers
Subject is male or female, ≥45 years of age (subjects aged 18-45 can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis)
Subject is able to understand the study procedures, and is able to provide consent to participate in the study and authorizes release of relevant protected health information through reviewing and consenting to a HIPAA medical release form
Subject is able and willing to provide stool samples within the 120 days prior to a colonoscopy procedure
Subject is able and willing to undergo a colonoscopy after providing a stool sample
Disqualifiers
Subject had any precancerous findings on most recent colonoscopy. This does not include benign, and/or hyperplastic polyps of any size
Subject has a history or diagnosis of colorectal cancer
Subject has a history of aerodigestive tract cancer
Fecal occult blood test or fecal immunochemical test within the previous twelve (12) months
Trial design
Treatments tested in this trial
- ColoSense
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov