Adenoma, Colon Cancer, Colon Diseases, Colon Lesion, Colon Neoplasm, Colon Polyp, Colorectal Cancer, Gastrointestinal Tract Cancers, Polyp, Rectal Cancer, Rectal Diseases
Conditions
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.
Interventions
DIAGNOSTIC_TESTFreenome test
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.
Sponsors
Freenome Holdings Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria 1. 45-85 years of age 2. Willing to undergo a standard-of-care screening colonoscopy 3. Able and willing to provide a blood sample 4. Able and willing to sign informed consent Key
Exclusion criteria
1. Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP) 2. Personal history 2.1 CRC or colorectal adenoma 2.2 Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and crohn's disease (CD) 2.3 Colonoscopy in the 9 years preceding enrollment 2.4 Stool DNA testing in the 2 years preceding enrollment 2.5 Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation 3. A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study 4. Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for Colorectal Cancer | 90 days | Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer |
| Positive Predictive Value for Advanced Colorectal Neoplasia | 90 days | Proportion of participants with a diagnosis of colorectal cancer or advanced precancerous lesions among those who had a positive test result |
| Negative Predictive Value for Advanced Colorectal Neoplasia | 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 |
| Specificity for Advanced Colorectal Neoplasia | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity for Advanced Precancerous Lesion | 90 days | Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Census-adjusted Sensitivity for Colorectal Cancer | 90 days | U.S. census sex- and age-adjusted sensitivity for colorectal cancer Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer |
| Census-adjusted Sensitivity for Advanced Precancerous Lesion | 90 days | U.S. census sex- and age-adjusted sensitivity for advanced precancerous lesion Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions |
| Census-adjusted Positive Predictive Value for Advanced Colorectal Neoplasia | 90 days | U.S. census sex- and age-adjusted 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 |
| Census-adjusted Negative Predictive Value for Advanced Colorectal Neoplasia | 90 days | U.S. census sex- and age-adjusted 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 |
| Census-adjusted Specificity for Advanced Colorectal Neoplasia | 90 days | U.S. census sex- and age-adjusted 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) |
Countries
Canada, United States
Participant flow
Recruitment details
Subjects who met the eligibility criteria and signed the informed consent were enrolled in the study.
Pre-assignment details
Of 48,995 subjects enrolled in the PREEMPT CRC study, 32,731 consecutively enrolled on or after a pre-specified cut-off date were included in the clinical validation cohort. 27,010 subjects from the clinical validation cohort were evaluable with confirmed clinical findings and valid blood test results.
Participants by arm
| Arm | Count |
|---|---|
| Evaluable Subjects Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results. | 27,010 |
| Total | 27,010 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Blood Test and/or Colonoscopy Reasons | 4,766 |
| Overall Study | Enrolled prior to the Pre-specified Cut-off Date | 16,264 |
| Overall Study | Lost to Follow-up | 182 |
| Overall Study | Withdrawal by Subject | 773 |
Baseline characteristics
| Characteristic | Evaluable Subjects |
|---|---|
| Age, Continuous | 58.1 Years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3189 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22421 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1400 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 78 Participants |
| Race (NIH/OMB) Asian | 2381 Participants |
| Race (NIH/OMB) Black or African American | 3038 Participants |
| Race (NIH/OMB) More than one race | 136 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 72 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1598 Participants |
| Race (NIH/OMB) White | 19707 Participants |
| Sex: Female, Male Female | 15076 Participants |
| Sex: Female, Male Male | 11934 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31,888 |
| other Total, other adverse events | 83 / 31,888 |
| serious Total, serious adverse events | 0 / 31,888 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Negative Predictive Value for Advanced Colorectal Neoplasia | 90.8 Percent |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Positive Predictive Value for Advanced Colorectal Neoplasia | 15.5 Percent |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Sensitivity for Colorectal Cancer | 79.2 Percent |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Specificity for Advanced Colorectal Neoplasia | 91.5 Percent |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Sensitivity for Advanced Precancerous Lesion | 12.5 Percent |
Other Pre-specified
Census-adjusted Negative Predictive Value for Advanced Colorectal Neoplasia
U.S. census sex- and age-adjusted 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Census-adjusted Negative Predictive Value for Advanced Colorectal Neoplasia | 90.5 Percent |
Other Pre-specified
Census-adjusted Positive Predictive Value for Advanced Colorectal Neoplasia
U.S. census sex- and age-adjusted 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Census-adjusted Positive Predictive Value for Advanced Colorectal Neoplasia | 15.5 Percent |
Other Pre-specified
Census-adjusted Sensitivity for Advanced Precancerous Lesion
U.S. census sex- and age-adjusted 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Census-adjusted Sensitivity for Advanced Precancerous Lesion | 13.7 Percent |
Other Pre-specified
Census-adjusted Sensitivity for Colorectal Cancer
U.S. census sex- and age-adjusted 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Census-adjusted Sensitivity for Colorectal Cancer | 81.1 Percent |
Other Pre-specified
Census-adjusted Specificity for Advanced Colorectal Neoplasia
U.S. census sex- and age-adjusted 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evaluable Subjects | Census-adjusted Specificity for Advanced Colorectal Neoplasia | 90.4 Percent |