AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test

Completed

Conditions studied: Colo-rectal Cancer, Cancer Colon, Cancer, Rectum, Neoplasms,Colorectal, Polyps, Polyp of Colon, Adenoma, Adenoma Colon

In brief

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 study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.

Key facts

Study ID

NCT03688906

Run by

Freenome Holdings Inc.

People needed

3275

Starts

2018-01-12

Expected to finish

2019-11-25

Last updated by the study team

2022-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 50-84 years of age (inclusive) at the time of screening
• Recently diagnosed with (or strong clinical suspicion for) primary colorectal cancer or advanced adenoma with plans to surgically or endoscopically remove the target lesion(s)
• At least 7 days before but no more than 6 months after the most recent colonoscopy
• Able and willing to provide blood and stool (optional) samples per protocol
• Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
• Key Exclusion Criteria:
• Personal history of colorectal cancer, colorectal adenomas (excluding non-adenomatous (e.g., hyperplastic polyps)) or aerodigestive tract cancer (other than most recent diagnosis)
• Colonoscopy within the previous 9 years (other than most recent diagnosis)
• Overt rectal bleeding within the previous 30 days
• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Have participated or be 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.
• If female, known to be pregnant.
• COHORT B
• Inclusion Criteria:
• 50-84 years of age (inclusive) at the time of screening
• Planning to undergo a screening colonoscopy within 75 days after providing signed informed consent
• Able and willing to provide blood and stool (optional) samples per protocol
• Able to comprehend and willing to sign and date the written informed consent document(s) and any applicable medical record release documents for the study
• Key Exclusion Criteria:
• Personal history of colorectal cancer, colorectal adenoma (excluding non-adenomatous (e.g., hyperplastic polyps)) or aerodigestive tract cancer
• Colonoscopy within the previous 9 years
• Overt rectal bleeding within the previous 30 days
• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Have participated or be 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.
• If female, known to be pregnant.

You may not qualify if…

• Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
• Have participated or be 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.
• If female, be known to be pregnant.

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Del Sol Research Management — Chandler, Arizona, United States
• Del Sol Research Management, — Tucson, Arizona, United States
• Del Sol Research Management — Tucson, Arizona, United States
• Preferred Research Partners — Little Rock, Arkansas, United States
• Precision Research Institute — Chula Vista, California, United States
• Diverse Research Solutions — Oxnard, California, United States
• Precision Research Institute — San Diego, California, United States
• Gastroenterology Associates of Fairfield County — Bridgeport, Connecticut, United States
• Palmetto Research — Hialeah, Florida, United States
• Clinical Research of Homestead — Homestead, Florida, United States
• Advanced Gastroenterology Associates, LLC — Palm Harbor, Florida, United States
• Rockford Gastroenterology — Rockford, Illinois, United States
• Delta Research Partners — Bastrop, Louisiana, United States
• New Orleans Research Institute — Metairie, Louisiana, United States
• Louisiana Research Center — Shreveport, Louisiana, United States
• Commonwealth Clinical Studies — Brockton, Massachusetts, United States
• Quality Clinical Research — Omaha, Nebraska, United States
• Asheville Gastroenterology Associates — Asheville, North Carolina, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cumberland Research Associates — Fayetteville, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Trial Management Associates — Wilmington, North Carolina, United States
• The Jackson Clinic — Jackson, Tennessee, United States
• Advanced Research Institute — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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