AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
- Conditions
- Colo-rectal CancerCancer ColonPolypsCancer, RectumNeoplasms,ColorectalPolyp of ColonAdenomaAdenoma Colon
- Registration Number
- NCT03688906
- Lead Sponsor
- Freenome Holdings Inc.
- 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.
- Detailed Description
Early detection of cancer combined with effective treatment improves survival and quality of life. Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in the blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay for the early detection of colorectal cancer. The study will collect blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas. A blood-based test for colorectal cancer and pre-cancerous lesions could offer an accurate, convenient, and patient-friendly screening option for current and future generations, and, in doing so, could save and improve lives by increasing adherence and early detection.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3275
- 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
- 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.
COHORT C
Inclusion Criteria:
- 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:
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnosis of colorectal cancer or advanced adenomas in patients undergoing routine screening colonoscopy, or post-colonoscopy 6 months Clinically annotated plasma samples from participants will undergo multi-omic analyses to characterize cell-free biomarkers.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (28)
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Palmetto Research
🇺🇸Hialeah, Florida, United States
Advanced Gastroenterology Associates, LLC
🇺🇸Palm Harbor, Florida, United States
Commonwealth Clinical Studies
🇺🇸Brockton, Massachusetts, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Diverse Research Solutions
🇺🇸Oxnard, California, United States
Del Sol Research Management
🇺🇸Tucson, Arizona, United States
Del Sol Research Management,
🇺🇸Tucson, Arizona, United States
Precision Research Institute
🇺🇸San Diego, California, United States
Delta Research Partners
🇺🇸Bastrop, Louisiana, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
New Orleans Research Institute
🇺🇸Metairie, Louisiana, United States
Asheville Gastroenterology Associates
🇺🇸Asheville, North Carolina, United States
Forzani and MacPhail Colon Cancer Screening Centre
🇨🇦Calgary, Alberta, Canada
Verity Research Inc
🇺🇸Fairfax, Virginia, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Rockford Gastroenterology
🇺🇸Rockford, Illinois, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Trial Management Associates
🇺🇸Wilmington, North Carolina, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
Washington Gastroenterology
🇺🇸Bellevue, Washington, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Clinical Research of Homestead
🇺🇸Homestead, Florida, United States