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Prevention of Colorectal Cancer Through Multiomics Blood Testing (PREEMPT CRC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369053
Recruitment Status : Active, not recruiting
First Posted : April 30, 2020
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Freenome Holdings Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Colon Cancer Rectal Cancer Colon Neoplasm Colon Diseases Colon Lesion Colon Polyp Colorectal Cancer Polyp Adenoma Rectal Diseases Gastrointestinal Tract Cancers Diagnostic Test: Freenome test

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of Colorectal Cancer Through Multiomics Blood Testing
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 2024
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Freenome 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.
    Other Name: Single Group Assignment

Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity for CRC of the Freenome test [ Time Frame: 90 days ]
  2. Specificity of the Freenome test [ Time Frame: 90 days ]

Biospecimen Retention:   Samples With DNA
Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants aged between 45 and 85 who are eligible for CRC screening and scheduled for a standard-of-care screening colonoscopy.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369053


Locations
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Sponsors and Collaborators
Freenome Holdings Inc.
Investigators
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Principal Investigator: Aasma Shaukat, MD MPH University of Minnesota
Principal Investigator: Theodore R Levin, MD The Permanente Medical Group
Study Chair: Lance Baldo, MD Freenome Holdings Inc.
More Information
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Responsible Party: Freenome Holdings Inc.
ClinicalTrials.gov Identifier: NCT04369053    
Other Study ID Numbers: FRNM-004
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Freenome Holdings Inc.:
Artificial Intelligence
Liquid Biopsy
Blood Test Cancer
Cancer Diagnostic
Genomics
Genomics Test
CRC
Cancer Screening
 Cancer Early Detection Test
Screening
Colonoscopy
Machine Learning
Freenome Test
Colorectal Cancer (CRC)
Colorectal Cancer Screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Adenoma
Gastrointestinal Neoplasms
Rectal Diseases
Colonic Diseases
Polyps
Intestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type