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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)

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ClinicalTrials.gov Identifier: NCT04369053
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Freenome Holdings Inc.

Tracking Information
First Submitted Date April 27, 2020
First Posted Date April 30, 2020
Last Update Posted Date May 4, 2021
Actual Study Start Date May 20, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 27, 2020)
  • Sensitivity for CRC of the Freenome test [ Time Frame: 90 days ]
  • Specificity of the Freenome test [ Time Frame: 90 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevention of Colorectal Cancer Through Multiomics Blood Testing
Official Title Prevention of Colorectal Cancer Through Multiomics Blood Testing
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood specimens will be de-identified and used to validate the performance characteristics of the Freenome test.
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.
Condition
  • Colon Cancer
  • Rectal Cancer
  • Colon Neoplasm
  • Colon Diseases
  • Colon Lesion
  • Colon Polyp
  • Colorectal Cancer
  • Polyp
  • Adenoma
  • Rectal Diseases
  • Gastrointestinal Tract Cancers
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 3, 2021)
25000
Original Estimated Enrollment
 (submitted: April 27, 2020)
14000
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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)

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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Chuanbo Xu, PhD 650-762-9937 research@freenome.com
Contact: Staci McAdams research@freenome.com
Listed Location Countries United States,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT04369053
Other Study ID Numbers FRNM-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Freenome Holdings Inc.
Study Sponsor Freenome Holdings Inc.
Collaborators Not Provided
Investigators
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
PRS Account Freenome Holdings Inc.
Verification Date May 2021