Trial Outcomes & Findings for Prevention of Colorectal Cancer Through Multiomics Blood Testing (NCT NCT04369053)

NCT ID: NCT04369053

Last Updated: 2025-12-26

Results Overview

Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer

• Recruitment status: COMPLETED
• Target enrollment: 48995 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2025-12-26

Participant Flow

Subjects who met the eligibility criteria and signed the informed consent were enrolled in the study.

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.

Participant milestones

Measure	Enrolled Subjects Study subjects who were aged 45 to 85 years, asymptomatic, at average risk of colorectal cancer, and willing to undergo a standard-of-care screening colonoscopy.
Overall Study STARTED	48995
Overall Study COMPLETED	27010
Overall Study NOT COMPLETED	21985

Reasons for withdrawal

Measure	Enrolled Subjects Study subjects who were aged 45 to 85 years, asymptomatic, at average risk of colorectal cancer, and willing to undergo a standard-of-care screening colonoscopy.
Overall Study Enrolled prior to the Pre-specified Cut-off Date	16264
Overall Study Withdrawal by Subject	773
Overall Study Lost to Follow-up	182
Overall Study Blood Test and/or Colonoscopy Reasons	4766

Baseline Characteristics

Prevention of Colorectal Cancer Through Multiomics Blood Testing

Baseline characteristics by cohort

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Age, Continuous	58.1 Years STANDARD_DEVIATION 8.2 • n=30 Participants
Sex: Female, Male Female	15076 Participants n=30 Participants
Sex: Female, Male Male	11934 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	78 Participants n=30 Participants
Race (NIH/OMB) Asian	2381 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	72 Participants n=30 Participants
Race (NIH/OMB) Black or African American	3038 Participants n=30 Participants
Race (NIH/OMB) White	19707 Participants n=30 Participants
Race (NIH/OMB) More than one race	136 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	1598 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3189 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22421 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1400 Participants n=30 Participants

PRIMARY outcome

Timeframe: 90 days

Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Sensitivity for Colorectal Cancer	79.2 Percent Interval 68.4 to 86.9

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Specificity for Advanced Colorectal Neoplasia	91.5 Percent Interval 91.2 to 91.9

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Negative Predictive Value for Advanced Colorectal Neoplasia	90.8 Percent Interval 90.7 to 90.9

PRIMARY outcome

Timeframe: 90 days

Proportion of participants with a diagnosis of colorectal cancer or advanced precancerous lesions among those who had a positive test result

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Positive Predictive Value for Advanced Colorectal Neoplasia	15.5 Percent Interval 14.2 to 16.8

SECONDARY outcome

Timeframe: 90 days

Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Sensitivity for Advanced Precancerous Lesion	12.5 Percent Interval 11.3 to 13.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Census-adjusted Sensitivity for Colorectal Cancer	81.1 Percent Interval 71.3 to 88.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Census-adjusted Specificity for Advanced Colorectal Neoplasia	90.4 Percent Interval 90.0 to 90.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Census-adjusted Negative Predictive Value for Advanced Colorectal Neoplasia	90.5 Percent Interval 90.4 to 90.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Census-adjusted Positive Predictive Value for Advanced Colorectal Neoplasia	15.5 Percent Interval 14.3 to 16.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Evaluable Subjects n=27010 Participants Subjects enrolled on or after the pre-specified cut-off date who had confirmed clinical findings and valid blood test results.
Census-adjusted Sensitivity for Advanced Precancerous Lesion	13.7 Percent Interval 12.4 to 15.0

Adverse Events

Safety Analysis Set

Serious events: 0 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Safety Analysis Set n=31888 participants at risk Subjects with attempted blood collection
General disorders Dizziness, syncope, contusion, and other observed minor complications	0.26% 83/31888 • Twenty-four hours within the study blood collection Pre-specified to only collect adverse events related to study blood collection

Additional Information

Director of Clinical Development

Freenome

Phone: (650)446-6630

Email: medicalaffairs@freenome.com

Results disclosure agreements

• Principal investigator is a sponsor employee At Sponsor's request, the PI shall remove any Confidential Information (other than Study Results) prior to submitting or presenting the materials. Upon Sponsor's request, PI shall further delay publication or presentation for x period of days to allow Sponsor to protect its interests in any Sponsor Inventions described in any materials.
• Publication restrictions are in place

Restriction type: OTHER