IRB #

STUDY00022989

Title

Project Danube: Multi-Cancer and Comorbidity Blood Sample Collection for Cross-Reactivity Analysis for a Multiomics CRC Screening Test

Principal Investigator

Tom Beer

Study Purpose

The purpose of this study is to determine the efficacy of Freenome's blood test for Colorectal Carcinoma (CRC) and advanced adenoma (polyp or small cluster of cells) among various non-CRC cancer types and non-cancerous gastrointestinal diseases.

Medical Condition(s)

Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease, Breast Cancer, Prostate Cancer, Lung Cancer, Liver Cancer, Pancreatic Cancer, Stomach Cancer, Genitourinary Cancer, Gynecological Cancer, Upper Gastrointestinal Cancer, Hematologic Malignancies.

Eligibility Criteria

1. 45-85 years of age within 30 days of enrollment.
2. Negative for CRC and adenomas (polyp or small cluster of cells) screening results in the number of years prior to enrollment through chart review or self-reporting: colonoscopy 9 years, sigmoidoscopy or CT colonography 4 years, or stool DNA test 2 years.
3. Should meet one of the following conditions at the time of enrollment:
a) Clinical diagnosis with histopathlological confirmation (including staging) of single primary cancer of the breast, prostate, lung, liver, pancreas, stomach, genitourinary, gynecological, upper gastrointestinal, and hematologic malignancies must be present.
b) Clinical diagnosis of Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis (UC) or Crohn's Disease (CD) must be present.
c) No history of Cancer.
4. Able and willing to provide blood samples per protocol prior to any types of treatments (systemic and/or non-systemic treatments, such as surgery, radiation or chemotherapy).
5. Able to comprehend and willing to sign and date the informed consent document(s).

Age Range

45 - 85

Healthy Volunteers Needed

Yes

Duration of Participation

The study will consist of 1 visit. Study duration for each participant will be approximately 30 minutes to go over eligibility, medical history, and blood sample collection. Participants in the Control Cohort may also be contacted by site personnel once a year for up to 3 years following the completion of the study to gather additional information (e.g., any new cancer diagnosis).

Minors Included

No

Contact

cedartrials@ohsu.edu
503-418-8150

Sponsor

Freenome, Inc.

Recruitment End

04/21/2026

Compensation Provided

Yes

Compensation

$100 reimbursement for travel and parking expenses.


Go Back