AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
NCT ID: NCT03688906
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3275 participants
OBSERVATIONAL
2018-01-12
2019-11-25
Brief Summary
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Detailed Description
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Freenome is looking for three types of patients in this study:
Cohort A:
People ages 50-84 who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.
Cohort B:
People ages 50-84 undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical check-ups. Blood samples must be collected before bowel preparation for the colonoscopy.
Cohort C:
People 18 years or older who have been recently diagnosed with (or strong clinical suspicion for) colorectal cancer or advanced adenoma. Blood samples must be collected before any cancer treatment has been initiated.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Cohort A
Blood and stool specimen collection.
Study samples must be collected prior to any treatment.
No interventions assigned to this group
Cohort B
Blood and stool specimen collection.
Samples must be collected prior to performing bowel preparation for the colonoscopy.
No interventions assigned to this group
Cohort C
Blood and stool specimen collection.
Study samples must be collected prior to any treatment.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* At least 18 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
Exclusion Criteria
* 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
* 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.
COHORT C
* 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.
18 Years
ALL
Yes
Sponsors
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Freenome Holdings Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Girish Putcha, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Freenome Holdings Inc.
Locations
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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
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Verity Research Inc
Fairfax, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Washington Gastroenterology
Bellevue, Washington, United States
Forzani and MacPhail Colon Cancer Screening Centre
Calgary, Alberta, Canada
Countries
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References
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Putcha G, Liu T-Y, Ariazi E, Bertin M, Drake A, Dzamba M, Hogan G, Kothen-Hill S, Liao J, Li K, Mahajan S, Palaniappan K, Sansanwal P, St John J, Ulz P, Wan N, Warsinske H, Weinberg D, Yang R, Lin J. Blood-based detection of early-stage colorectal cancer using multiomics and machine learning. [Abstract] J Clin Oncol 38 (Suppl 4): A-66, 2020.
Other Identifiers
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AI-EMERGE/FRE-001
Identifier Type: -
Identifier Source: org_study_id
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