Spots Global Cancer Trial Database for AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
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Trial Identification
Brief Title: AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
Official Title: Specimen Collection Study for Cancer
Study ID: NCT03688906
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
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
Contact Details
Name: Girish Putcha, M.D., Ph.D
Affiliation: Freenome Holdings Inc.
Role: PRINCIPAL_INVESTIGATOR
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