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Trial record 1 of 1 for:    FRNM-004 | United States
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369053
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Freenome Holdings Inc.

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.

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Study Type : Observational
Estimated Enrollment : 14000 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 : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine



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


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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


Contacts
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Contact: Andrea Valencia, MS 6507616919 research@freenome.com
Contact: Chuanbo Xu, PhD research@freenome.com

Locations
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Sponsors and Collaborators
Freenome Holdings Inc.
Investigators
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Principal Investigator: Girish Putcha, MD PhD Freenome Holdings Inc.
Principal Investigator: Aasma Shaukat, MD MPH University of Minnesota
Principal Investigator: Theodore R Levin, MD The Permanente Medical Group
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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: November 3, 2020
Last Verified: September 2020
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