AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
Specimen Collection Study for Cancer
1 other identifier
observational
3,275
2 countries
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2018
CompletedFirst Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
September 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2019
CompletedMarch 2, 2022
February 1, 2022
1.9 years
August 27, 2018
February 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnosis of colorectal cancer or advanced adenomas in patients undergoing routine screening colonoscopy, or post-colonoscopy
Clinically annotated plasma samples from participants will undergo multi-omic analyses to characterize cell-free biomarkers.
6 months
Study Arms (3)
Cohort A
Blood and stool specimen collection. Study samples must be collected prior to any treatment.
Cohort B
Blood and stool specimen collection. Samples must be collected prior to performing bowel preparation for the colonoscopy.
Cohort C
Blood and stool specimen collection. Study samples must be collected prior to any treatment.
Eligibility Criteria
Subjects for the study will be enrolled into three cohorts: * 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.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- 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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Del Sol Research Management
Chandler, Arizona, 85224, United States
Del Sol Research Management,
Tucson, Arizona, 85710, United States
Del Sol Research Management
Tucson, Arizona, 85745, United States
Preferred Research Partners
Little Rock, Arkansas, 72211, United States
Precision Research Institute
Chula Vista, California, 91910, United States
Diverse Research Solutions
Oxnard, California, 93030, United States
Precision Research Institute
San Diego, California, 92114, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Palmetto Research
Hialeah, Florida, 33016, United States
Clinical Research of Homestead
Homestead, Florida, 33030, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, 34684, United States
Rockford Gastroenterology
Rockford, Illinois, 61107, United States
Delta Research Partners
Bastrop, Louisiana, 71220, United States
New Orleans Research Institute
Metairie, Louisiana, 70006, United States
Louisiana Research Center
Shreveport, Louisiana, 71105, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Trial Management Associates
Wilmington, North Carolina, 28403, United States
The Jackson Clinic
Jackson, Tennessee, 38305, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320, United States
Verity Research Inc
Fairfax, Virginia, 22031, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Washington Gastroenterology
Bellevue, Washington, 98004, United States
Forzani and MacPhail Colon Cancer Screening Centre
Calgary, Alberta, T2N 4Z6, Canada
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Girish Putcha, M.D., Ph.D
Freenome Holdings Inc.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2018
First Posted
September 28, 2018
Study Start
January 12, 2018
Primary Completion
November 25, 2019
Study Completion
November 25, 2019
Last Updated
March 2, 2022
Record last verified: 2022-02