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
This trial accepts healthy volunteersQualifiers
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 population
Subjects aged 45 years or older, who are at typical average-risk of developing colorectal neoplasms and are considered enrolled after understanding and consenting to ICF. Additional subjects outside the intended us population can be enrolled onto the clinical trial but are not eligible for primary endpoint analysis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ColoSense
Devicemulti-target stool RNA test
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
CRC Sensitivity
ColoSense sensitivity for subjects with colorectal cancer (CRC), which is the percentage of individuals with a diagnosis of CRC that were detected as positive by the ColoSense test.
Time frame
Through study completion, an average of 5 years.2
AA Sensitivity
ColoSense sensitivity for subjects with advanced adenomas (AA), which is the percentage of individuals with a diagnosis of AA that were detected as positive by the ColoSense test.
Time frame
Through study completion, an average of 5 years.3
SPL Sensitivity
ColoSense sensitivity for subjects with serrated precancerous lesions (SPL), which is the percentage of individuals with a diagnosis of SPL that were detected as positive by the ColoSense test.
Time frame
Through study completion, an average of 5 years.4
NEG Specificity
ColoSense specificity for subjects with negative findings, which is the percentage of individuals with a diagnosis of negative findings that were detected as negative by the ColoSense test.
Time frame
Through study completion, an average of 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov