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Forebyggelse af kolorektal cancer gennem multiomisk blodprøve (PREEMPT CRC)

26. februar 2024 opdateret af: Freenome Holdings Inc.
PREEMPT CRC-studiet er et prospektivt multicenter-observationsstudie for at validere en blodbaseret test til tidlig påvisning af tyktarmskræft ved at indsamle blodprøver fra deltagere med gennemsnitlig risiko, som vil gennemgå en rutinemæssig screening-koloskopi.

Studieoversigt

Detaljeret beskrivelse

Freenome bruger en type kunstig intelligens, kaldet machine learning, til at identificere mønstre af cellefri biomarkører i blodet for at opdage kræft tidligt. Formålet med denne prospektive multicenter-observationsundersøgelse er at validere en blodbaseret test til påvisning af tyktarmskræft ved at indsamle blodprøver fra deltagere med gennemsnitlig risiko, som vil gennemgå en rutinemæssig screening koloskopi.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

50000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Abu Dhabi, Forenede Arabiske Emirater
        • Cleveland Clinic Abu Dhabi
    • Alabama
      • Anniston, Alabama, Forenede Stater, 36207
        • Pinnacle Research Group LLC
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Forenede Stater, 35233
        • Birmingham VA Medical Center - Alabama
      • Homewood, Alabama, Forenede Stater, 35209
        • Birmingham Gastroenterology Associates
    • Arizona
      • Chandler, Arizona, Forenede Stater, 85224
        • Advanced Gastroenterology PC
      • Chandler, Arizona, Forenede Stater, 85224
        • Southeast Valley Gastro (SEVG)
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Associated Gastroenterology Medical Group
      • Beverly Hills, California, Forenede Stater, 90212
        • Matrix Clinical Research
      • Chula Vista, California, Forenede Stater, 91910
        • Precision Research Institute, Llc
      • Covina, California, Forenede Stater, 91722
        • Citrus Valley Gastroenterology
      • Downey, California, Forenede Stater, 90242
        • Kaiser Permanente Southern California
      • Garden Grove, California, Forenede Stater, 92840
        • Paragon Rx Clinical - Garden Grove
      • Lancaster, California, Forenede Stater, 93534
        • Gastro Care Institute
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA Medical Center
      • Los Angeles, California, Forenede Stater, 90094
        • Science 37
      • Mission Viejo, California, Forenede Stater, 92691
        • St. Joseph Heritage Healthcare
      • Murrieta, California, Forenede Stater, 92562
        • Inland Empire GI
      • Northridge, California, Forenede Stater, 91325
        • Los Angeles Gastroenterology Institute
      • Oakland, California, Forenede Stater, 94612
        • East Bay Center for Digestive Health
      • Orange, California, Forenede Stater, 92868
        • Knowledge Research Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Institute for Medical Research
      • San Diego, California, Forenede Stater, 92103
        • University of California San Diego Medical Center
      • San Diego, California, Forenede Stater, 92114
        • Precision Research Institute, Llc
      • San Francisco, California, Forenede Stater, 94115
        • UCSF Mount Zion Medical Center
      • Santa Ana, California, Forenede Stater, 92703
        • Paragon Rx Clinical - Santa Ana
      • Santa Monica, California, Forenede Stater, 90404
        • Digestive Health Associates
      • Walnut Creek, California, Forenede Stater, 94596
        • Kaiser Permanente Northern California
      • Walnut Creek, California, Forenede Stater, 94598
        • Clinical Research of California LLC
    • Connecticut
      • Greenwich, Connecticut, Forenede Stater, 06831
        • The Center for Gastrointestinal Medicine of Fairfield and Westchester, P.C
      • Prospect, Connecticut, Forenede Stater, 06712
        • Naugatuck Valley GI Consultants
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Delaware Center for Digestive Care
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20422
        • Veterans Affairs Medical Center
    • Florida
      • Bay Pines, Florida, Forenede Stater, 33744
        • Bay Pines VA Healthcare System
      • Boca Raton, Florida, Forenede Stater, 33433
        • Hillel Cohen, MD
      • Doral, Florida, Forenede Stater, 33166
        • Universal Axon Clinical Research
      • Hialeah, Florida, Forenede Stater, 33016
        • Palmetto Research, LLC
      • Hollywood, Florida, Forenede Stater, 33021
        • The Center for Gastrointestinal Disorders
      • Jacksonville, Florida, Forenede Stater, 32256
        • ENCORE
      • Kissimmee, Florida, Forenede Stater, 34744
        • Central Florida Gastro Research
      • Kissimmee, Florida, Forenede Stater, 34741
        • IHS Health
      • Miami, Florida, Forenede Stater, 33126
        • Pharmax Research Clinic
      • Ocala, Florida, Forenede Stater, 34471
        • Ocala GI Research
      • Saint Augustine, Florida, Forenede Stater, 32086
        • St. Johns Center for Clinical Research
      • Zephyrhills, Florida, Forenede Stater, 33542
        • Florida Medical Clinic, LLC
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30310
        • Morehouse
      • Atlanta, Georgia, Forenede Stater, 30342
        • Metro Atlanta Gastroenterology, LLC
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University
      • Columbus, Georgia, Forenede Stater, 31904
        • IACT Health
      • Conyers, Georgia, Forenede Stater, 30322
        • Emory University School of Medicine
      • Evans, Georgia, Forenede Stater, 30809
        • Gastroenterology Consultants of Augusta
      • Marietta, Georgia, Forenede Stater, 30060
        • Gastrointestinal Specialists of Georgia
      • Roswell, Georgia, Forenede Stater, 30076
        • Pramukh Clinical Research
      • Savannah, Georgia, Forenede Stater, 31405
        • Gastroenterology Consultants of Savannah, PC
      • Waycross, Georgia, Forenede Stater, 31501
        • Southeast Georgia Gastroenterology, P.C.
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
      • Downers Grove, Illinois, Forenede Stater, 60515
        • Digestive Health Services, a Division of GI Partners of Illinios
      • Evanston, Illinois, Forenede Stater, 60201
        • Northshore University Health System
      • Hines, Illinois, Forenede Stater, 60141
        • Edward Hines, Jr. VA Hospital
      • Naperville, Illinois, Forenede Stater, 60540
        • Suburban Gastroenterology
      • New Lenox, Illinois, Forenede Stater, 60451
        • Digestive Diseases Consultants of Kankakee
      • Oak Lawn, Illinois, Forenede Stater, 60453
        • GI Partners of Illinois - Southwest Gastroenerology
      • Quincy, Illinois, Forenede Stater, 62301
        • Quincy Medical Group
      • Springfield, Illinois, Forenede Stater, 62702
        • Springfield Clinic, Llp
    • Indiana
      • Muncie, Indiana, Forenede Stater, 47304
        • American Health Network of Indiana, LLC
      • South Bend, Indiana, Forenede Stater, 46635
        • Digestive Research Alliance of Michiana
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Medical Center Research Institute, Inc.
      • Topeka, Kansas, Forenede Stater, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
      • Wichita, Kansas, Forenede Stater, 67226
        • Kansas Gastroenterology, LLC
    • Kentucky
      • Crestview Hills, Kentucky, Forenede Stater, 41017
        • Tri-State Gastroenterology Associates, PSC
    • Louisiana
      • Bastrop, Louisiana, Forenede Stater, 71220
        • Delta Research Partners - Bastrop
      • Hammond, Louisiana, Forenede Stater, 70403
        • Northlake Gastroenterology Associates
      • Monroe, Louisiana, Forenede Stater, 71201
        • Delta Research Parnters - Monroe
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, Forenede Stater, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21208
        • Woodholme Gastroenterology Associates
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Chevy Chase Clinical Research
      • Columbia, Maryland, Forenede Stater, 21045
        • Gastro Center of Maryland
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
      • Framingham, Massachusetts, Forenede Stater, 01702
        • Greater Boston Gastroenterology
      • South Weymouth, Massachusetts, Forenede Stater, 02190
        • South Suburban Gastroenterology
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota
    • Mississippi
      • Columbus, Mississippi, Forenede Stater, 39705
        • Gastroenterology Associates of Mississippi
      • Flowood, Mississippi, Forenede Stater, 39232
        • Gastrointestinal Associates
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
        • Gastrointestinal Associates
      • Kansas City, Missouri, Forenede Stater, 64128
        • Kansas City VA Medical Center
      • Washington, Missouri, Forenede Stater, 63090
        • Mercy Washington
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89113
        • LV Gastroenterology Associates
      • North Las Vegas, Nevada, Forenede Stater, 89086
        • VA Southern Nevada
      • Reno, Nevada, Forenede Stater, 89511
        • Advanced Research Institute
      • Reno, Nevada, Forenede Stater, 89502
        • VA Sierra Nevada
    • New Jersey
      • Dover, New Jersey, Forenede Stater, 07801
        • Gastroenterology Associates in NJ
      • Florham Park, New Jersey, Forenede Stater, 07932
        • AIG Digestive Disease Research
      • Hillsborough, New Jersey, Forenede Stater, 08844
        • Digestive Healthcare Center
      • North Bergen, New Jersey, Forenede Stater, 07047
        • Gastroenterology Medical Associates
      • Ocean City, New Jersey, Forenede Stater, 07712
        • Dr. Howard N. Guss and Dr. Gagan Beri
      • Princeton, New Jersey, Forenede Stater, 08540
        • Princeton GI Associates
      • Teaneck, New Jersey, Forenede Stater, 07666
        • Teaneck Gastroenterology Associates
      • Toms River, New Jersey, Forenede Stater, 08755
        • Ocean Family Gastroenterology
      • Union, New Jersey, Forenede Stater, 07083
        • Advanced Gasteroenterology Group
      • Union, New Jersey, Forenede Stater, 07083
        • Center for Digestive Diseases
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Samuel S. Stratton VA Medical Center
      • Brooklyn, New York, Forenede Stater, 11234
        • Sam Moskowitz, MD
      • Camillus, New York, Forenede Stater, 13031
        • Associated Gastroenterologists of Central NY
      • Great Neck, New York, Forenede Stater, 11023
        • North Shore Gastroenterology Associates
      • Lawrence, New York, Forenede Stater, 11559
        • South Island Gastro
      • Manorville, New York, Forenede Stater, 11949
        • Mark Coronel, MD
      • New City, New York, Forenede Stater, 10956
        • Gastrointestinal Associates of Rockland
      • New Windsor, New York, Forenede Stater, 12553
        • Mid Hudson Medical Research, PLLC
      • New York, New York, Forenede Stater, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, Forenede Stater, 10016
        • NYU Grossman School of Medicine
      • New York, New York, Forenede Stater, 10065
        • Cornell
      • Syracuse, New York, Forenede Stater, 13210
        • Syracuse Gastroenterological Associates, PC
      • Valley Stream, New York, Forenede Stater, 11581
        • GastroCare LI
      • Wantagh, New York, Forenede Stater, 11793
        • Long Island Gastrointestinal Specialist
      • West Nyack, New York, Forenede Stater, 10994
        • William S. Silver MD & Eric L. Tatar MD PC.
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27518
        • Cary Gastro Associates
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Clinic
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Carolina's GI Research, LLC
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • PMG Research of Winston-Salem, LLC
    • North Dakota
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Health Center Medical Arts
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45255
        • Cincinnati GI
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation - Central
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Wexner Medical Center
      • Mentor, Ohio, Forenede Stater, 44060
        • Great Lakes Gastroenterology Research, LLC
      • Springboro, Ohio, Forenede Stater, 45066
        • DSI Research
    • Oregon
      • Bend, Oregon, Forenede Stater, 97701
        • Summit Medical Group Oregon - BMC
      • Portland, Oregon, Forenede Stater, 97201
        • Oregon Health & Science University
      • Portland, Oregon, Forenede Stater, 97220
        • The Oregon Clinic, P.C.
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18104
        • Eastern Pennsylvania GI & Liver Specialist
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Blair Gastroenterology Associates
      • Beaver Falls, Pennsylvania, Forenede Stater, 15010
        • Valley Gastroenterology Associates
      • Camp Hill, Pennsylvania, Forenede Stater, 17011
        • Susquehanna Research Group, LLC
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19014
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC Digestive Diseases Center GAS
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • Southeast Medical Research II, LLC
      • Greenville, South Carolina, Forenede Stater, 29601
        • Gastroenterology Associates, PA
      • Greenwood, South Carolina, Forenede Stater, 29646
        • Digestive Disease Research Center
      • West Columbia, South Carolina, Forenede Stater, 29169
        • Consultants in GI
    • Tennessee
      • Franklin, Tennessee, Forenede Stater, 37067
        • ARCare Center of Clinical Research
      • Johnson City, Tennessee, Forenede Stater, 37604
        • Gastrointestinal Associates of NorthEast Tenn
      • Kingsport, Tennessee, Forenede Stater, 37663
        • Tri-Cities Gastroenterology
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Gastroenterology Associates, PC
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, Forenede Stater, 37208
        • Meharry Medical College
      • Union City, Tennessee, Forenede Stater, 38261
        • Advanced Gastroenterology
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Texas Oncology
      • Arlington, Texas, Forenede Stater, 76018
        • Gastroenterology Practice Associates
      • Cypress, Texas, Forenede Stater, 77429
        • Mohan, Uma Yanamadala
      • Dallas, Texas, Forenede Stater, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Ertan Digestive Disease Center
      • Houston, Texas, Forenede Stater, 77034
        • Gastroenterology Consults
      • Houston, Texas, Forenede Stater, 77070
        • Hope Digestive and Liver Disease Clinic of Houston
      • Houston, Texas, Forenede Stater, 77080
        • Panamericana Family Medicine Clinic
      • McAllen, Texas, Forenede Stater, 78503
        • Rio Grande Gastroenterology
      • Pasadena, Texas, Forenede Stater, 77505
        • Digestive System Healthcare
      • Pasadena, Texas, Forenede Stater, 77504
        • Gastroenterology Consultants
      • Shenandoah, Texas, Forenede Stater, 77384
        • Gastroenterology Partners of North Houston
      • Tomball, Texas, Forenede Stater, 77375
        • Texas Gastro Consultants
      • Tyler, Texas, Forenede Stater, 75702
        • Texas Oncology
      • Tyler, Texas, Forenede Stater, 75708
        • University of Texas Health Science Center at Tyler
      • Wichita Falls, Texas, Forenede Stater, 76301
        • Digestive Health Research of North Texas
    • Utah
      • Ogden, Utah, Forenede Stater, 84405
        • Advanced Research Institute
      • Salt Lake City, Utah, Forenede Stater, 84119
        • Intermountain
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23502
        • Digestive and Liver Disease Specialists, Ltd.
      • Roanoke, Virginia, Forenede Stater, 24014
        • Gastroenterology Consultants of SW Virginia
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • UW Medical Center
      • Tacoma, Washington, Forenede Stater, 98405
        • Washington Gastroenterology - Tacoma Clinic
    • Wisconsin
      • Wausau, Wisconsin, Forenede Stater, 54401
        • GastroIntestinal Associates, S.C.
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82601
        • Gastroenterology Associates of Wyoming

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

43 år til 83 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Deltagere i alderen mellem 45 og 85, som er berettiget til CRC-screening og planlagt til en standard-of-care screening koloskopi.

Beskrivelse

Nøgleinklusionskriterier

  1. 45-85 år
  2. Villig til at gennemgå en standard-of-care screening koloskopi
  3. Kan og er villig til at tage en blodprøve
  4. Kan og er villig til at underskrive informeret samtykke

Nøgleudelukkelseskriterier

  1. Kendt arvelig gastrointestinal cancer syndrom (for eksempel arvelig non-polypose CRC syndrom (HNPCC) eller Lynch syndrom eller familiær adenomatøs polypose (FAP)
  2. Personlig anamnese 2.1 CRC eller kolorektalt adenom 2.2 Inflammatorisk tarmsygdom (IBD), herunder kronisk colitis ulcerosa (CUC) og crohns sygdom (CD) 2.3 Koloskopi i de 9 år forud for indskrivning 2.4 Afførings-DNA-test i de 2 år forud for indskrivning 25. mave-tarmkanalen sygdom, der berettiger koloskopisk evaluering
  3. En medicinsk tilstand, som efter Investigators opfattelse bør udelukke optagelse i undersøgelsen
  4. Deltog eller deltager i øjeblikket i et klinisk forskningsstudie, hvor en eksperimentel medicin er blevet administreret i løbet af de 60 dage til og med datoen for afgivelse af informeret samtykke eller kan administreres gennem tidspunktet for koloskopi

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Følsomhed for CRC i Freenome-testen
Tidsramme: 90 dage
90 dage
Specificitet af Freenome-testen
Tidsramme: 90 dage
90 dage

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Aasma Shaukat, MD MPH, University of Minnesota
  • Ledende efterforsker: Theodore R Levin, MD, The Permanente Medical Group
  • Studiestol: Lance Baldo, MD, Freenome Holdings Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2020

Primær færdiggørelse (Anslået)

30. maj 2024

Studieafslutning (Anslået)

30. maj 2024

Datoer for studieregistrering

Først indsendt

27. april 2020

Først indsendt, der opfyldte QC-kriterier

27. april 2020

Først opslået (Faktiske)

30. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2024

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2024

Sidst verificeret

1. februar 2024

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Endetarmssygdomme

Kliniske forsøg med Freenome test

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