ColoSense Post Approval Study
Summary
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.
Arms & interventions
- DeviceColoSense
multi-target stool RNA test
Outcome measures
Primary
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.
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.
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.
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.
Eligibility criteria
Study locations (1)
Decentralized Study
St Louis, Missouri, 63146