Prevention of Colorectal Cancer Through Multiomics Blood Testing

  • STATUS
    Recruiting
  • End date
    Jul 30, 2021
  • participants needed
    14000
  • sponsor
    Freenome Holdings Inc.
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Updated on 24 December 2020
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Investigator
Andrea Valencia, MS
Primary Contact
Clinical Research of California (0.9 mi away) Contact
+110 other location
cancer
early detection
blood test
screening colonoscopy
colorectal cancer screening
preempt
colonoscopy
screening for colorectal cancer
blood testing
prevention of colorectal cancer

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.

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.

Details
Treatment Freenome test
Clinical Study IdentifierNCT04369053
SponsorFreenome Holdings Inc.
Last Modified on24 December 2020

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Eligibility

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Inclusion Criteria

Is your age between 45 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Colon Cancer or Polyps or Malignant neoplasm of colon or Intestinal Diseases or Rectal Cancer or COLONIC POLYP or Colon cancer; rectal cancer or Gastr...?
Do you have any of these conditions: Colonic Diseases or Colon Polyps or Neoplasm of unspecified nature of digestive system or Rectal Cancer or Colon cancer; rectal cancer or colorectal n...?
Do you have any of these conditions: colorectal tumor or gastrointestinal cancers or Colon Cancer or Malignant neoplasm of colon or Colorectal Cancer or Neoplasm of unspecified nature of ...?
Do you have any of these conditions: Intestinal Diseases or Gastrointestinal Neoplasm or cancer, colorectal or Gastrointestinal Diseases and Disorders or Digestive System Neoplasms or Col...?
Do you have any of these conditions: gastrointestinal cancer or COLONIC POLYP or Rectal Cancer or Polyps or colorectal neoplasm or Polyp or gastrointestinal cancers or cancer, colorectal ...?
45-85 years of age
Willing to undergo a standard-of-care screening colonoscopy
Able and willing to provide a blood sample
Able and willing to sign informed consent

Exclusion Criteria

Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP)
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
A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study
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
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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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