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NCT04369053 Clinical Trial

Prevention of Colorectal Cancer Through Multiomics Blood Testing

Colorectal Cancer Clinical Trial

— PREEMPT CRC  

Official title:
Prevention of Colorectal Cancer Through Multiomics Blood Testing

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04369053
Other study ID # FRNM-004
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 20, 2020
Est. completion date May 30, 2024

Study information
Verified date February 2024
Source Freenome Holdings Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Description:

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 prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50000
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 85 Years
Eligibility Key Inclusion Criteria 1. 45-85 years of age 2. Willing to undergo a standard-of-care screening colonoscopy 3. Able and willing to provide a blood sample 4. Able and willing to sign informed consent Key Exclusion Criteria 1. Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP) 2. Personal history 2.1 CRC or colorectal adenoma 2.2 Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and crohn's disease (CD) 2.3 Colonoscopy in the 9 years preceding enrollment 2.4 Stool DNA testing in the 2 years preceding enrollment 2.5 Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation 3. A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study 4. Participated or 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Freenome test
Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.

Locations
Country Name City State
United Arab Emirates Cleveland Clinic Abu Dhabi Abu Dhabi
United States Samuel S. Stratton VA Medical Center Albany New York
United States Eastern Pennsylvania GI & Liver Specialist Allentown Pennsylvania
United States Blair Gastroenterology Associates Altoona Pennsylvania
United States Texas Oncology Amarillo Texas
United States Associated Gastroenterology Medical Group Anaheim California
United States Pinnacle Research Group LLC Anniston Alabama
United States Gastroenterology Practice Associates Arlington Texas
United States Metro Atlanta Gastroenterology, LLC Atlanta Georgia
United States Morehouse Atlanta Georgia
United States Augusta University Augusta Georgia
United States Woodholme Gastroenterology Associates Baltimore Maryland
United States Delta Research Partners - Bastrop Bastrop Louisiana
United States Bay Pines VA Healthcare System Bay Pines Florida
United States Valley Gastroenterology Associates Beaver Falls Pennsylvania
United States Summit Medical Group Oregon - BMC Bend Oregon
United States Matrix Clinical Research Beverly Hills California
United States Birmingham VA Medical Center - Alabama Birmingham Alabama
United States University of Alabama at Birmingham Birmingham Alabama
United States Hillel Cohen, MD Boca Raton Florida
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Sam Moskowitz, MD Brooklyn New York
United States Associated Gastroenterologists of Central NY Camillus New York
United States Susquehanna Research Group, LLC Camp Hill Pennsylvania
United States Cary Gastro Associates Cary North Carolina
United States Gastroenterology Associates of Wyoming Casper Wyoming
United States Advanced Gastroenterology PC Chandler Arizona
United States Southeast Valley Gastro (SEVG) Chandler Arizona
United States University of North Carolina Chapel Hill North Carolina
United States Southeast Medical Research II, LLC Charleston South Carolina
United States Chevy Chase Clinical Research Chevy Chase Maryland
United States University of Chicago Chicago Illinois
United States Precision Research Institute, LLC Chula Vista California
United States Cincinnati GI Cincinnati Ohio
United States Cleveland Clinic Foundation - Central Cleveland Ohio
United States Gastro Center of Maryland Columbia Maryland
United States Gastrointestinal Associates Columbia Missouri
United States Gastroenterology Associates of Mississippi Columbus Mississippi
United States IACT Health Columbus Georgia
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Emory University School of Medicine Conyers Georgia
United States Citrus Valley Gastroenterology Covina California
United States Tri-State Gastroenterology Associates, PSC Crestview Hills Kentucky
United States Mohan, Uma Yanamadala Cypress Texas
United States University of Texas Southwestern Medical Center Dallas Texas
United States Universal Axon Clinical Research Doral Florida
United States Gastroenterology Associates in NJ Dover New Jersey
United States Digestive Health Services, a Division of GI Partners of Illinios Downers Grove Illinois
United States Kaiser Permanente Southern California Downey California
United States Duke Clinic Durham North Carolina
United States Gastroenterology Consultants of Augusta Evans Georgia
United States NorthShore University Health System Evanston Illinois
United States AIG Digestive Disease Research Florham Park New Jersey
United States Gastrointestinal Associates Flowood Mississippi
United States Greater Boston Gastroenterology Framingham Massachusetts
United States ARCare Center of Clinical Research Franklin Tennessee
United States Paragon Rx Clinical - Garden Grove Garden Grove California
United States North Shore Gastroenterology Associates Great Neck New York
United States Gastroenterology Associates, PA Greenville South Carolina
United States The Center for Gastrointestinal Medicine of Fairfield and Westchester, P.C Greenwich Connecticut
United States Digestive Disease Research Center Greenwood South Carolina
United States Northlake Gastroenterology Associates Hammond Louisiana
United States Palmetto Research, LLC Hialeah Florida
United States Digestive Healthcare Center Hillsborough New Jersey
United States Edward Hines, Jr. VA Hospital Hines Illinois
United States The Center for Gastrointestinal Disorders Hollywood Florida
United States Birmingham Gastroenterology Associates Homewood Alabama
United States Ertan Digestive Disease Center Houston Texas
United States Gastroenterology Consults Houston Texas
United States Hope Digestive and Liver Disease Clinic of Houston Houston Texas
United States Panamericana Family Medicine Clinic Houston Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States ENCORE Jacksonville Florida
United States Gastrointestinal Associates of NorthEast Tenn Johnson City Tennessee
United States Kansas City VA Medical Center Kansas City Missouri
United States University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas
United States Tri-Cities Gastroenterology Kingsport Tennessee
United States Central Florida Gastro Research Kissimmee Florida
United States IHS Health Kissimmee Florida
United States Gastroenterology Associates, PC Knoxville Tennessee
United States Gastro Care Institute Lancaster California
United States LV Gastroenterology Associates Las Vegas Nevada
United States South Island Gastro Lawrence New York
United States Science 37 Los Angeles California
United States UCLA Medical Center Los Angeles California
United States Mark Coronel, MD Manorville New York
United States Gastrointestinal Specialists of Georgia Marietta Georgia
United States Rio Grande Gastroenterology McAllen Texas
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States Pharmax Research Clinic Miami Florida
United States University of Minnesota Minneapolis Minnesota
United States Trinity Health Center Medical Arts Minot North Dakota
United States St. Joseph Heritage Healthcare Mission Viejo California
United States Delta Research Parnters - Monroe Monroe Louisiana
United States American Health Network of Indiana, LLC Muncie Indiana
United States Inland Empire GI Murrieta California
United States Suburban Gastroenterology Naperville Illinois
United States Meharry Medical College Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Gastrointestinal Associates of Rockland New City New York
United States Digestive Diseases Consultants of Kankakee New Lenox Illinois
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Mid Hudson Medical Research, PLLC New Windsor New York
United States Cornell New York New York
United States Icahn School of Medicine at Mount Sinai New York New York
United States NYU Grossman School of Medicine New York New York
United States Delaware Center for Digestive Care Newark Delaware
United States Digestive and Liver Disease Specialists, Ltd. Norfolk Virginia
United States Gastroenterology Medical Associates North Bergen New Jersey
United States VA Southern Nevada North Las Vegas Nevada
United States Los Angeles Gastroenterology Institute Northridge California
United States GI Partners of Illinois - Southwest Gastroenerology Oak Lawn Illinois
United States East Bay Center for Digestive Health Oakland California
United States Ocala GI Research Ocala Florida
United States Dr. Howard N. Guss and Dr. Gagan Beri Ocean City New Jersey
United States Advanced Research Institute Ogden Utah
United States Knowledge Research Center Orange California
United States Digestive System Healthcare Pasadena Texas
United States Gastroenterology Consultants Pasadena Texas
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States UPMC Digestive Diseases Center GAS Pittsburgh Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States The Oregon Clinic, P.C. Portland Oregon
United States Princeton GI Associates Princeton New Jersey
United States Naugatuck Valley GI Consultants Prospect Connecticut
United States Quincy Medical Group Quincy Illinois
United States Carolina's GI Research, LLC Raleigh North Carolina
United States Advanced Research Institute Reno Nevada
United States VA Sierra Nevada Reno Nevada
United States Gastroenterology Consultants of SW Virginia Roanoke Virginia
United States Pramukh Clinical Research Roswell Georgia
United States Sutter Institute for Medical Research Sacramento California
United States St. Johns Center for Clinical Research Saint Augustine Florida
United States Intermountain Salt Lake City Utah
United States Precision Research Institute, LLC San Diego California
United States University of California San Diego Medical Center San Diego California
United States UCSF Mount Zion Medical Center San Francisco California
United States Paragon Rx Clinical - Santa Ana Santa Ana California
United States Digestive Health Associates Santa Monica California
United States Gastroenterology Consultants of Savannah, PC Savannah Georgia
United States UW Medical Center Seattle Washington
United States Gastroenterology Partners of North Houston Shenandoah Texas
United States Louisiana Research Center, LLC Shreveport Louisiana
United States Digestive Research Alliance of Michiana South Bend Indiana
United States South Suburban Gastroenterology South Weymouth Massachusetts
United States DSI Research Springboro Ohio
United States Springfield Clinic, LLP Springfield Illinois
United States Syracuse Gastroenterological Associates, PC Syracuse New York
United States Washington Gastroenterology - Tacoma Clinic Tacoma Washington
United States Teaneck Gastroenterology Associates Teaneck New Jersey
United States Texas Gastro Consultants Tomball Texas
United States Ocean Family Gastroenterology Toms River New Jersey
United States Cotton-O'Neil Clinical Research Center, Digestive Health Topeka Kansas
United States Texas Oncology Tyler Texas
United States University of Texas Health Science Center at Tyler Tyler Texas
United States Advanced Gasteroenterology Group Union New Jersey
United States Center for Digestive Diseases Union New Jersey
United States Advanced Gastroenterology Union City Tennessee
United States GastroCare LI Valley Stream New York
United States Clinical Research of California LLC Walnut Creek California
United States Kaiser Permanente Northern California Walnut Creek California
United States Long Island Gastrointestinal Specialist Wantagh New York
United States Mercy Washington Washington Missouri
United States Veterans Affairs Medical Center Washington District of Columbia
United States GastroIntestinal Associates, S.C. Wausau Wisconsin
United States Southeast Georgia Gastroenterology, P.C. Waycross Georgia
United States Consultants in GI West Columbia South Carolina
United States William S. Silver MD & Eric L. Tatar MD PC. West Nyack New York
United States Kansas Gastroenterology, LLC Wichita Kansas
United States Digestive Health Research of North Texas Wichita Falls Texas
United States PMG Research of Winston-Salem, LLC Winston-Salem North Carolina
United States Florida Medical Clinic, LLC Zephyrhills Florida

Sponsors (1)
Lead Sponsor Collaborator
Freenome Holdings Inc.

Countries where clinical trial is conducted

United States,  United Arab Emirates, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity for CRC of the Freenome test 90 days
Primary Specificity of the Freenome test 90 days
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