Clinical trial NCT04369053: Prevention of Colorectal Cancer Through Multiomics Blood Testing
Official title: Prevention of Colorectal Cancer Through Multiomics Blood Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Rectal Cancer
Colon Neoplasm
Colon Diseases
Colon Lesion
Colon Polyp
Colorectal Cancer
Polyp
Adenoma
Rectal Diseases
Gastrointestinal Tract Cancers
Keywords: Artificial Intelligence
Liquid Biopsy
Blood Test Cancer
Cancer Diagnostic
Genomics
Genomics Test
CRC
Cancer Screening
Cancer Early Detection Test
Screening
Colonoscopy
Machine Learning
Freenome Test
Colorectal Cancer (CRC)
Colorectal Cancer Screening
Lead sponsor: Freenome Holdings Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-30
Enrollment: 48995
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged between 45 and 85 who are eligible for CRC screening and scheduled for a standard-of-care screening colonoscopy.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity for CRC of the Freenome test
timeFrame: 90 days
measure: Specificity of the Freenome test
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group LLC
state: Alabama
city: Birmingham
country: United States
facility: Birmingham VA Medical Center - Alabama
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Homewood
country: United States
facility: Birmingham Gastroenterology Associates
state: Alabama
city: Chandler
country: United States
facility: Advanced Gastroenterology PC
state: Arizona
city: Chandler
country: United States
facility: Southeast Valley Gastro (SEVG)
state: Arizona
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Little Rock
country: United States
facility: Premier Gastroenterology Associates-Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: ARCare Center of Clinical Research
state: Arkansas
city: Anaheim
country: United States
facility: Associated Gastroenterology Medical Group
state: California
city: Chula Vista
country: United States
facility: Precision Research Institute, LLC
state: California
city: Covina
country: United States
facility: Citrus Valley Gastroenterology
state: California
city: Downey
country: United States
facility: Kaiser Permanente Southern California
state: California
city: Garden Grove
country: United States
facility: Paragon Rx Clinical - Garden Grove
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: Los Angeles
country: United States
facility: Science 37
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Mission Viejo
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Murrieta
country: United States
facility: Inland Empire GI
state: California
city: Northridge
country: United States
facility: Los Angeles Gastroenterology Institute
state: California
city: Oakland
country: United States
facility: East Bay Center for Digestive Health
state: California
city: Orange
country: United States
facility: Knowledge Research Center
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: San Diego
country: United States
facility: Precision Research Institute, LLC
state: California
city: San Francisco
country: United States
facility: UCSF Mount Zion Medical Center
state: California
city: Santa Ana
country: United States
facility: Paragon Rx Clinical - Santa Ana
state: California
city: Santa Monica
country: United States
facility: Digestive Health Associates
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Walnut Creek
country: United States
facility: Clinical Research of California LLC
state: California
city: Denver
country: United States
facility: Denver Digestive Health Specialists
state: Colorado
city: Greenwich
country: United States
facility: The Center for Gastrointestinal Medicine of Fairfield and Westchester, P.C
state: Connecticut
city: Prospect
country: United States
facility: Naugatuck Valley GI Consultants
state: Connecticut
city: Newark
country: United States
facility: Delaware Center for Digestive Care
state: Delaware
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Washington
country: United States
facility: Veterans Affairs Medical Center
state: District of Columbia
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Boca Raton
country: United States
facility: Hillel Cohen, MD
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Palmetto Research, LLC
state: Florida
city: Hollywood
country: United States
facility: The Center for Gastrointestinal Disorders
state: Florida
city: Jacksonville
country: United States
facility: ENCORE Borland Groover Clinical Research
state: Florida
city: Kissimmee
country: United States
facility: IHS Health
state: Florida
city: Kissimmee
country: United States
facility: Central Florida Gastro Research
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Ocala
country: United States
facility: Ocala GI Research
state: Florida
city: Orlando
country: United States
facility: Center For Digestive Endoscopy
state: Florida
city: Saint Augustine
country: United States
facility: St. Johns Center for Clinical Research
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, LLC
state: Florida
city: Atlanta
country: United States
facility: Morehouse
state: Georgia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Metro Atlanta Gastroenterology, LLC
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Evans
country: United States
facility: Gastroenterology Consultants of Augusta
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Roswell
country: United States
facility: Pramukh Clinical Research
state: Georgia
city: Waycross
country: United States
facility: Southeast Georgia Gastroenterology, P.C.
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Downers Grove
country: United States
facility: Digestive Health Services, a Division of GI Partners of Illinios
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Naperville
country: United States
facility: Suburban Gastroenterology
state: Illinois
city: New Lenox
country: United States
facility: Digestive Diseases Consultants of Kankakee
state: Illinois
city: Oak Lawn
country: United States
facility: GI Partners of Illinois - Southwest Gastroenerology
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic, LLP
state: Illinois
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC
state: Indiana
city: South Bend
country: United States
facility: Digestive Research Alliance of Michiana
state: Indiana
city: Fairway
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Newton
country: United States
facility: AMR Newton
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center, Digestive Health
state: Kansas
city: Wichita
country: United States
facility: AMR West Wichita
state: Kansas
city: Wichita
country: United States
facility: Kansas Gastroenterology, LLC
state: Kansas
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Associates, PSC
state: Kentucky
city: Bastrop
country: United States
facility: Delta Research Partners - Bastrop
state: Louisiana
city: Covington
country: United States
facility: Northlake Gastroenterology Associates
state: Louisiana
city: Lafayette
country: United States
facility: Acadiana Gi Associates - Louisiana
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Parnters - Monroe
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Woodholme Gastroenterology Associates
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Framingham
country: United States
facility: Greater Boston Gastroenterology
state: Massachusetts
city: South Weymouth
country: United States
facility: South Suburban Gastroenterology
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Columbus
country: United States
facility: Gastroenterology Associates of Mississippi
state: Mississippi
city: Flowood
country: United States
facility: Gastrointestinal Associates
state: Mississippi
city: Flowood
country: United States
facility: GI Associates and Endoscopy Center
state: Mississippi
city: Columbia
country: United States
facility: Gastrointestinal Associates
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Washington
country: United States
facility: Mercy Clinic Gastroenterology
state: Missouri
city: Las Vegas
country: United States
facility: LV Gastroenterology Associates
state: Nevada
city: North Las Vegas
country: United States
facility: VA Southern Nevada
state: Nevada
city: Reno
country: United States
facility: VA Sierra Nevada
state: Nevada
city: Reno
country: United States
facility: Advanced Research Institute
state: Nevada
city: Charleston
country: United States
facility: Digestive Disease Center of New Jersey
state: New Jersey
city: Clifton
country: United States
facility: Gastroenterology Associates of NJ (GANJ)
state: New Jersey
city: Florham Park
country: United States
facility: AIG Digestive Disease Research
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack Digestive Disease Associate
state: New Jersey
city: Hillsborough
country: United States
facility: Digestive Healthcare Center
state: New Jersey
city: Montclair
country: United States
facility: Gastroenterology Associates of New Jersey
state: New Jersey
city: North Bergen
country: United States
facility: Gastroenterology Medical Associates
state: New Jersey
city: Ocean City
country: United States
facility: Dr. Howard N. Guss and Dr. Gagan Beri
state: New Jersey
city: Princeton
country: United States
facility: Princeton GI Associates
state: New Jersey
city: Ridgewood
country: United States
facility: Gastroenterology Associates of New Jersey
state: New Jersey
city: Teaneck
country: United States
facility: Teaneck Gastroenterology Associates
state: New Jersey
city: Toms River
country: United States
facility: Ocean Family Gastroenterology
state: New Jersey
city: Union
country: United States
facility: Advanced Gasteroenterology Group
state: New Jersey
city: Union
country: United States
facility: Center for Digestive Diseases
state: New Jersey
city: Voorhees
country: United States
facility: Allied Gastrointestinal Associates P.A
state: New Jersey
city: Wayne
country: United States
facility: Gastroenterology Associates of New Jersey(2)
state: New Jersey
city: Wayne
country: United States
facility: Gastroenterology Associates of New Jersey(8)
state: New Jersey
city: Wayne
country: United States
facility: North Jersey Gastroenterology
state: New Jersey
city: Woodland Park
country: United States
facility: Gastroenterology Associates of New Jersey
state: New Jersey
city: Albany
country: United States
facility: Samuel S. Stratton VA Medical Center
state: New York
city: Brooklyn
country: United States
facility: Gastroenterology Consultants of Brookyln
state: New York
city: Brooklyn
country: United States
facility: Sam Moskowitz, MD
state: New York
city: Camillus
country: United States
facility: Associated Gastroenterologists of Central NY
state: New York
city: Great Neck
country: United States
facility: North Shore Gastroenterology Associates
state: New York
city: Lawrence
country: United States
facility: South Island Gastro
state: New York
city: Manorville
country: United States
facility: East End Gastroenterology and Hepatology
state: New York
city: New City
country: United States
facility: Gastrointestinal Associates of Rockland
state: New York
city: New Windsor
country: United States
facility: Mid Hudson Medical Research, PLLC
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Syracuse
country: United States
facility: Syracuse Gastroenterological Associates, PC
state: New York
city: Valley Stream
country: United States
facility: GastroCare LI
state: New York
city: Wantagh
country: United States
facility: Long Island Gastrointestinal Specialist
state: New York
city: West Nyack
country: United States
facility: William S. Silver MD & Eric L. Tatar MD PC.
state: New York
city: Cary
country: United States
facility: Cary Gastro Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Carolina's GI Research, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Minot
country: United States
facility: Trinity Health Center Medical Arts
state: North Dakota
city: Beachwood
country: United States
facility: Gastroenterology Associates of Cleveland, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati GI
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation - Central
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Springboro
country: United States
facility: DSI Research
state: Ohio
city: Bend
country: United States
facility: Summit Medical Group Oregon - BMC
state: Oregon
city: Portland
country: United States
facility: The Oregon Clinic, P.C.
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Allentown
country: United States
facility: Eastern Pennsylvania GI & Liver Specialist
state: Pennsylvania
city: Allentown
country: United States
facility: Gastroenterology Associates, Ltd.
state: Pennsylvania
city: Altoona
country: United States
facility: Blair Gastroenterology Associates
state: Pennsylvania
city: Beaver Falls
country: United States
facility: Valley Gastroenterology Associates
state: Pennsylvania
city: Harrisburg
country: United States
facility: Susquehanna Research Group, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Digestive Diseases Center GAS
state: Pennsylvania
city: Charleston
country: United States
facility: Southeast Medical Research II, LLC
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Columbia
country: United States
facility: Consultants in GI
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Inst
state: South Carolina
city: Greenville
country: United States
facility: Gastroenterology Associates, PA
state: South Carolina
city: Greenwood
country: United States
facility: Digestive Disease Research Center
state: South Carolina
city: Johnson City
country: United States
facility: GI Gastrointestinal Associates of NorthEast Tennessee
state: Tennessee
city: Kingsport
country: United States
facility: Gastroenterology Associates
state: Tennessee
city: Kingsport
country: United States
facility: Tri-Cities Gastroenterology
state: Tennessee
city: Knoxville
country: United States
facility: Gastroenterology Associates, PC
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Union City
country: United States
facility: Advanced Gastroenterology
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology
state: Texas
city: Arlington
country: United States
facility: Gastroenterology Practice Associates
state: Texas
city: Bryan
country: United States
facility: Central Texas GI Consultants
state: Texas
city: Cypress
country: United States
facility: Biopharma Informatic, Inc. Research Center
state: Texas
city: Cypress
country: United States
facility: Mohan, Uma Yanamadala
state: Texas
city: Houston
country: United States
facility: Ertan Digestive Disease Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Gastroenterology Consults
state: Texas
city: Houston
country: United States
facility: Hope Digestive and Liver Disease Clinic of Houston
state: Texas
city: Houston
country: United States
facility: Panamericana Family Medicine Clinic
state: Texas
city: McAllen
country: United States
facility: Rio Grande Gastroenterology
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - McKinney/Allen
state: Texas
city: Pasadena
country: United States
facility: Gastroenterology Consultants
state: Texas
city: Pasadena
country: United States
facility: Digestive System Healthcare
state: Texas
city: Shenandoah
country: United States
facility: Gastroenterology Partners of North Houston
state: Texas
city: Tomball
country: United States
facility: Texas Gastro Consultants
state: Texas
city: Tyler
country: United States
facility: Texas Oncology
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
city: Wichita Falls
country: United States
facility: Digestive Health Research of North Texas
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Salt Lake City
country: United States
facility: Intermountain
state: Utah
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists, Ltd.
state: Virginia
city: Roanoke
country: United States
facility: Gastroenterology Consultants of SW Virginia
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: UW Medical Center
state: Washington
city: Tacoma
country: United States
facility: Washington Gastroenterology - Tacoma Clinic
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Wausau
country: United States
facility: GastroIntestinal Associates, S.C.
state: Wisconsin
city: Casper
country: United States
facility: Gastroenterology Associates of Wyoming
state: Wyoming
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic Abu Dhabi
Study officials:
affiliation: University of Minnesota
name: Aasma Shaukat, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Permanente Medical Group
name: Theodore R Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Freenome Holdings Inc.
name: Lance Baldo, MD
role: STUDY_CHAIR
References: