Prevention of Colorectal Cancer Through Multiomics Blood Testing
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colon Cancer
- Sponsor
- Freenome Holdings Inc.
- Enrollment
- 48995
- Locations
- 148
- Primary Endpoint
- Sensitivity for Colorectal Cancer
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.
Detailed Description
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Sensitivity for Colorectal Cancer
Time Frame: 90 days
Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer
Specificity for Advanced Colorectal Neoplasia
Time Frame: 90 days
Proportion of participants with a negative test result among those who had non-advanced precancerous lesions or negative findings (non-neoplastic or no findings)
Negative Predictive Value for Advanced Colorectal Neoplasia
Time Frame: 90 days
Proportion of participants with a diagnosis of non-advanced precancerous lesions or negative findings (non-neoplastic or no findings) among those who had a negative test result
Positive Predictive Value for Advanced Colorectal Neoplasia
Time Frame: 90 days
Proportion of participants with a diagnosis of colorectal cancer or advanced precancerous lesions among those who had a positive test result
Secondary Outcomes
- Sensitivity for Advanced Precancerous Lesion(90 days)