Adults 45 to 85, any sex, with Colon Cancer or Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Sensitivity for Colorectal CancerPrimary· 90 days
Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer
Group
Value
95% CI
Evaluable Subjects
79.2
68.4 – 86.9
Specificity for Advanced Colorectal NeoplasiaPrimary· 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)
Group
Value
95% CI
Evaluable Subjects
91.5
91.2 – 91.9
Negative Predictive Value for Advanced Colorectal NeoplasiaPrimary· 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
Group
Value
95% CI
Evaluable Subjects
90.8
90.7 – 90.9
Positive Predictive Value for Advanced Colorectal NeoplasiaPrimary· 90 days
Proportion of participants with a diagnosis of colorectal cancer or advanced precancerous lesions among those who had a positive test result
Group
Value
95% CI
Evaluable Subjects
15.5
14.2 – 16.8
Sensitivity for Advanced Precancerous LesionSecondary· 90 days
Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions
Group
Value
95% CI
Evaluable Subjects
12.5
11.3 – 13.8
Census-adjusted Sensitivity for Colorectal CancerSecondary· 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
Group
Value
95% CI
Evaluable Subjects
81.1
71.3 – 88.1
Census-adjusted Specificity for Advanced Colorectal NeoplasiaSecondary· 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)
Group
Value
95% CI
Evaluable Subjects
90.4
90.0 – 90.7
Census-adjusted Negative Predictive Value for Advanced Colorectal NeoplasiaSecondary· 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
Group
Value
95% CI
Evaluable Subjects
90.5
90.4 – 90.7
Census-adjusted Positive Predictive Value for Advanced Colorectal NeoplasiaSecondary· 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
Group
Value
95% CI
Evaluable Subjects
15.5
14.3 – 16.7
Census-adjusted Sensitivity for Advanced Precancerous LesionSecondary· 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
Group
Value
95% CI
Evaluable Subjects
13.7
12.4 – 15.0
Adverse events — posted to ClinicalTrials.gov
Time frame: Twenty-four hours within the study blood collection.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Safety Analysis Set
Serious: 0/31888 (0%)
Deaths: 0/31888
Other adverse events (1 terms — click to expand)
Reaction
System
Safety Analysis Set
Dizziness, syncope, contusion, and other observed minor complications
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06923787 — Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patient
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· recruiting
NCT07279077 — Node-Sparing Low-Dose Radiotherapy Concurrent With Chemotherapy and PD-1 Inhibitor in pMMR/MSS High-Risk Locally Advance
· Phase 2
· recruiting
NCT07205965 — The Effect of Acceptance and Commitment Approach-Based Psychoeducation in Cancer Survivors
· NA
· active not recruiting
NCT07285356 — Study to Evaluate the Use of Surgical Gloves for the Prevention of Oxaliplatin-Induced Peripheral Neuropathy
· NA
· recruiting
NCT07161713 — SBU-RESET: RElaxation, Stress Reduction and Epigenetics Trial in Cancer Survivors
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Freenome Holdings Inc.
Last refreshed: 26 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04369053.