An observational study in Colon Cancer, Rectal Cancer and Colon Neoplasm, sponsored by Freenome Holdings Inc.. Completed at 148 sites in 2 countries. Open to participants aged 45 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Freenome Holdings Inc. · Observational
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.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's enrollment of 48,995 is above the median of 227 across 555 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Freenome Holdings Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants aged between 45 and 85 who are eligible for CRC screening and scheduled for a standard-of-care screening colonoscopy.
Key Inclusion Criteria
Key Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Single Group Assignment
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
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
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
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
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
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
Subjects who met the eligibility criteria and signed the informed consent were enrolled in the study.
| Milestone | Enrolled Subjects |
|---|---|
| Started | 48995 |
| Completed | 27010 |
| Not completed | 21985 |
| Withdrew: Enrolled prior to the pre-specified cut-off date | 16264 |
| Withdrew: Withdrawal by subject | 773 |
| Withdrew: Lost to follow-up | 182 |
| Withdrew: Blood test and/or colonoscopy reasons | 4766 |
Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer
| Percent | Evaluable Subjects |
|---|---|
| Sensitivity for Colorectal Cancer | 79.2 (68.4 to 86.9) |
Proportion of participants with a negative test result among those who had non-advanced precancerous lesions or negative findings (non-neoplastic or no findings)
| Percent | Evaluable Subjects |
|---|---|
| Specificity for Advanced Colorectal Neoplasia | 91.5 (91.2 to 91.9) |
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
| Percent | Evaluable Subjects |
|---|---|
| Negative Predictive Value for Advanced Colorectal Neoplasia | 90.8 (90.7 to 90.9) |
Proportion of participants with a diagnosis of colorectal cancer or advanced precancerous lesions among those who had a positive test result
| Percent | Evaluable Subjects |
|---|---|
| Positive Predictive Value for Advanced Colorectal Neoplasia | 15.5 (14.2 to 16.8) |
Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions
| Percent | Evaluable Subjects |
|---|---|
| Sensitivity for Advanced Precancerous Lesion | 12.5 (11.3 to 13.8) |
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
| Percent | Evaluable Subjects |
|---|---|
| Census-adjusted Sensitivity for Colorectal Cancer | 81.1 (71.3 to 88.1) |
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)
| Percent | Evaluable Subjects |
|---|---|
| Census-adjusted Specificity for Advanced Colorectal Neoplasia | 90.4 (90.0 to 90.7) |
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
| Percent | Evaluable Subjects |
|---|---|
| Census-adjusted Negative Predictive Value for Advanced Colorectal Neoplasia | 90.5 (90.4 to 90.7) |
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
| Percent | Evaluable Subjects |
|---|---|
| Census-adjusted Positive Predictive Value for Advanced Colorectal Neoplasia | 15.5 (14.3 to 16.7) |
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
| Percent | Evaluable Subjects |
|---|---|
| Census-adjusted Sensitivity for Advanced Precancerous Lesion | 13.7 (12.4 to 15.0) |
Collected over Twenty-four hours within the study blood collection. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Safety Analysis Set | 0/31,888 (0%) | 0/31,888 (0%) | 83/31,888 (0.3%) |
| Event | Safety Analysis Set |
|---|---|
| Dizziness, syncope, contusion, and other observed minor complicationsGeneral disorders | 83/31888 |
Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
| Age, Continuous(Years) | Evaluable Subjects |
|---|---|
| Mean | 58.1 ± 8.2 |
| Sex: Female, Male(Participants) | Evaluable Subjects |
|---|---|
| Female | 15076 |
| Male | 11934 |
| Race (NIH/OMB)(Participants) | Evaluable Subjects |
|---|---|
| American Indian or Alaska Native | 78 |
| Asian | 2381 |
| Native Hawaiian or Other Pacific Islander | 72 |
| Black or African American | 3038 |
| White | 19707 |
| More than one race | 136 |
| Unknown or Not Reported | 1598 |
| Ethnicity (NIH/OMB)(Participants) | Evaluable Subjects |
|---|---|
| Hispanic or Latino | 3189 |
| Not Hispanic or Latino | 22421 |
| Unknown or Not Reported | 1400 |
Showing the first 100 of 148 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2020 to primary completion in Feb 2024, 45 months.
Results were first posted in Dec 2025, 1 year 9 months after primary completion.
Of 224 observational studies under Colonic Neoplasms, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's 45 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Freenome Holdings Inc.