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.
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.
Study Type
OBSERVATIONAL
Enrollment
48,995
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.
Central Alabama Research
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Clinical Research Associates
Huntsville, Alabama, United States
Del Sol Research Management
Chandler, Arizona, United States
Honor Health
Scottsdale, Arizona, United States
Del Sol Research Management,
Sensitivity for Colorectal Cancer
Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer
Time frame: 90 days
Specificity for Advanced Colorectal Neoplasia
Proportion of participants with a negative test result among those who had non-advanced precancerous lesions or negative findings (non-neoplastic or no findings)
Time frame: 90 days
Negative Predictive Value for Advanced Colorectal Neoplasia
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
Time frame: 90 days
Positive Predictive Value for Advanced Colorectal Neoplasia
Proportion of participants with a diagnosis of colorectal cancer or advanced precancerous lesions among those who had a positive test result
Time frame: 90 days
Sensitivity for Advanced Precancerous Lesion
Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions
Time frame: 90 days
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Tucson, Arizona, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Precision Research Institute
Chula Vista, California, United States
John Muir Health
Concord, California, United States
...and 138 more locations