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Evaluering af ctDNA LUNAR-testen i en gennemsnitlig patientscreeningsepisode (ECLIPSE)

26. april 2024 opdateret af: Guardant Health, Inc.

ECLIPSE-undersøgelsen (Evaluering af ctDNA LUNAR-testen i en gennemsnitlig patientscreeningsepisode) er en prospektiv, observationel multi-site undersøgelse uden randomisering. Det primære formål med undersøgelsen er at evaluere præstationskarakteristikaene for en blod-baseret ctDNA LUNAR-2-test for at påvise kolorektal cancer i en screen-relevant, gennemsnitlig risikopopulation.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Kolorektal cancer

Detaljeret beskrivelse

LUNAR-2-testen er udviklet til at påvise ondartet sygdom hos screen-relevante patienter, som ellers ville gennemgå screening for ondartet sygdom ved hjælp af invasive metoder såsom koloskopi. Den påtænkte anvendelse af en sådan test ville være at returnere et resultat af ctDNA påvist/ctDNA ikke påvist hos en patient, der er kvalificeret til gennemsnitlig risikoscreening for tyktarmskræft. De patienter, der modtager et ctDNA-detekteret resultat, bør gennemgå yderligere undersøgelse med koloskopi.

For at definere testens præstationskarakteristika i en relevant population, vil denne undersøgelse udføre en blodprøvetagning før patienten gennemgår standardbehandlingen koloskopi (og alle tilknyttede forberedende medicin) og retrospektivt sammenligne præstationskarakteristika for LUNAR-2 test med resultaterne af indekskoloskopien.

Resultater fra patienter et og to år efter proceduren vil blive indsamlet som sekundære endepunkter for at undersøge muligheden for tilfældige, ikke-kolorektale cancertilfælde og intervalcancer, der ikke havde nået den kliniske tærskel for detektion på tidspunktet for indekskoloskopien.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

44467

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- Alabama
  - Anniston, Alabama, Forenede Stater, 36207
    - Pinnacle Research Group, LLC
  - Guntersville, Alabama, Forenede Stater, 35976
    - Lakeview Clinical Research
  - Huntsville, Alabama, Forenede Stater, 35801
    - Medical Affiliated Research Center
  - Jasper, Alabama, Forenede Stater, 35501
    - Jasper Summit Research LLC
- Arizona
  - Chandler, Arizona, Forenede Stater, 85224
    - Hope Research Institute
  - Chandler, Arizona, Forenede Stater, 85224
    - Southeast Valley Gastroenterology
  - Gilbert, Arizona, Forenede Stater, 85296
    - Prime Medical Group, LLC
  - Glendale, Arizona, Forenede Stater, 85308
    - Hope Research Institute
  - Phoenix, Arizona, Forenede Stater, 85037
    - GI Research Associates, LLC
  - Phoenix, Arizona, Forenede Stater, 85051
    - "Forty-Third Medical Associates Absolute Clinical Research"
  - Tucson, Arizona, Forenede Stater, 85741
    - Novak Clinical Research
  - Tucson, Arizona, Forenede Stater, 85715
    - Del Sol Research Management, LLC
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72211
    - Preferred Research Partners, Inc
  - Little Rock, Arkansas, Forenede Stater, 72211
    - Premier Gastroenterology
  - North Little Rock, Arkansas, Forenede Stater, 72117
    - Arkansas Gastroenterology
- California
  - Anaheim, California, Forenede Stater, 92801
    - Associated Gastroenterology Medical Group
  - Arcadia, California, Forenede Stater, 91006
    - InSite Digestive Health Care
  - Burlingame, California, Forenede Stater, 94010
    - Gastroenterology
  - Camarillo, California, Forenede Stater, 93012
    - Ventura County Gastroenterology Medical Group
  - Canoga Park, California, Forenede Stater, 91303
    - Hope Clinical Research
  - Canoga Park, California, Forenede Stater, 91304
    - Alliance Research Institute
  - Chula Vista, California, Forenede Stater, 91910
    - Precision Research Institute
  - Chula Vista, California, Forenede Stater, 91910
    - Gastro SB Clinic
  - Encinitas, California, Forenede Stater, 92024
    - Diagnamics, Inc
  - Encinitas, California, Forenede Stater, 92024
    - BG Clinical Research and affiliate of The Clinical Trials Network, LLC
  - Fullerton, California, Forenede Stater, 92831
    - Helping Hands Healthcare Group
  - Garden Grove, California, Forenede Stater, 92840
    - Paragon Rx Clinical, Inc.
  - Huntington Beach, California, Forenede Stater, 92647
    - Digestive Health Research of Southern California
  - Irvine, California, Forenede Stater, 92618
    - United Medical Doctors
  - Lancaster, California, Forenede Stater, 93534
    - Gastro Care Institute
  - Los Angeles, California, Forenede Stater, 90033
    - University of Southern California
  - Los Angeles, California, Forenede Stater, 90004
    - LA Gastroenterology Group
  - Los Angeles, California, Forenede Stater, 90048
    - Gastroenterology Associates of Beverly Hills
  - Orange, California, Forenede Stater, 92868
    - Knowledge Research Center
  - Oxnard, California, Forenede Stater, 93030
    - InSite Digestive Health Care-San Gabriel
  - Palm Springs, California, Forenede Stater, 92262
    - Desert Oasis Healthcare Medical Group
  - Palm Springs, California, Forenede Stater, 92262
    - Palm Tree Clinical, Inc
  - Pasadena, California, Forenede Stater, 91105
    - InSite Digestive Health Care - Gastroenterology Associates
  - Sacramento, California, Forenede Stater, 95821
    - Northern California Research
  - San Diego, California, Forenede Stater, 92123
    - Medical Associates Research Group
  - San Diego, California, Forenede Stater, 92114
    - Precision Research Institute
  - San Diego, California, Forenede Stater, 92103
    - San Diego Gastroenterology Medical Associates
  - San Diego, California, Forenede Stater, 92103
    - SDG Clinical Research, Inc.
  - Thousand Oaks, California, Forenede Stater, 91360
    - FOMAT Simoni AGI Medical
  - Toluca Lake, California, Forenede Stater, 91602
    - Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc
  - Walnut Creek, California, Forenede Stater, 94598
    - Clinical Research of California
  - Walnut Creek, California, Forenede Stater, 91789
    - Curebase
- Connecticut
  - Bridgeport, Connecticut, Forenede Stater, 06606
    - Gastroenterology Associates of Fairfield County
  - Hamden, Connecticut, Forenede Stater, 06517
    - CMR of Greater New Haven, LLC
  - New Haven, Connecticut, Forenede Stater, 06519
    - Yale University
- Florida
  - Aventura, Florida, Forenede Stater, 33180
    - Innovative Medical Research of South Florida, Inc.
  - Boynton Beach, Florida, Forenede Stater, 33472
    - Reciomed Clinical Research Network, Inc.
  - Coral Gables, Florida, Forenede Stater, 33134
    - Clinical Research of South Florida, an AMR Company
  - Doral, Florida, Forenede Stater, 33172
    - Dolphin Medical Research
  - Gainesville, Florida, Forenede Stater, 32610
    - University of Florida College of Medicine
  - Hialeah, Florida, Forenede Stater, 33016
    - Palmetto Research, LLC
  - Hollywood, Florida, Forenede Stater, 33021
    - The Center for Gastrointestinal Disorders
  - Hollywood, Florida, Forenede Stater, 33024
    - Research Centers of America
  - Jupiter, Florida, Forenede Stater, 33458
    - Jupiter Medical Center
  - Jupiter, Florida, Forenede Stater, 33458
    - Health Awareness, Inc
  - Lake City, Florida, Forenede Stater, 32055
    - Multi-Specialty Research Associates
  - Lake Mary, Florida, Forenede Stater, 32746
    - University Clinical Research-DeLand, LLC dba Accel Research Sites
  - Lakewood Ranch, Florida, Forenede Stater, 34211
    - Florida Research Institute
  - Melbourne, Florida, Forenede Stater, 32901
    - University Clinical Research-DeLand, LLC dba Accel Research Sites
  - Miami Lakes, Florida, Forenede Stater, 33014
    - Crystal Biomedical Research
  - Ocala, Florida, Forenede Stater, 34474
    - Sarkis Clinical Trials
  - Ocala, Florida, Forenede Stater, 34471
    - Ocala GI Research, LLC
  - Orange City, Florida, Forenede Stater, 32763
    - Gastroenterology of Greater Orlando
  - Orlando, Florida, Forenede Stater, 32807
    - Gastroenterology Institute of Orlando
  - Palm Harbor, Florida, Forenede Stater, 34684
    - Advanced Gastroenterology Associates, LLC
  - Sunrise, Florida, Forenede Stater, 33351
    - Precision Clinical Research, LLC
  - Tampa, Florida, Forenede Stater, 33614
    - Guardian Angel Research Center, LLC
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Emory University School of Medicine
  - Atlanta, Georgia, Forenede Stater, 30309
    - Digestive Health Care of Georgia
  - Atlanta, Georgia, Forenede Stater, 30342
    - Metro Atlanta Gastroenterology, LLC.
  - Columbus, Georgia, Forenede Stater, 31904
    - Columbus Regional Research Institute
  - Evans, Georgia, Forenede Stater, 30809
    - Gastroenterology Consultants of Augusta
  - Lawrenceville, Georgia, Forenede Stater, 30044
    - SKY Clinical Research Network Group
  - Riverdale, Georgia, Forenede Stater, 30274
    - Infinite Clinical Trials
  - Sandy Springs, Georgia, Forenede Stater, 30328
    - WR-Mount Vernon Clinical Research, LLC
  - Union City, Georgia, Forenede Stater, 30291
    - Rolphe Adult and Pediatric Medicine
- Illinois
  - Champaign, Illinois, Forenede Stater, 61822
    - Christie Clinic
  - Chicago, Illinois, Forenede Stater, 60654
    - University of Chicago Medicine
  - Chicago, Illinois, Forenede Stater, 60656
    - Curebase
  - Downers Grove, Illinois, Forenede Stater, 60515
    - Digestive Health Services
  - Hines, Illinois, Forenede Stater, 60141
    - Edward Hines Jr. VA Hospital
  - Lake Barrington, Illinois, Forenede Stater, 60010
    - Gastroenterology & Internal Medicine Specialist, SC, Avicenna Clinical Research
  - Naperville, Illinois, Forenede Stater, 60540
    - Suburban Gastroenterology Ltd
  - Northbrook, Illinois, Forenede Stater, 60062
    - Comprehensive Gastrointestinal Health
  - Oak Lawn, Illinois, Forenede Stater, 60453
    - DM Clinical Research
  - Rockford, Illinois, Forenede Stater, 61107
    - Rockford Gastroenterology Associates, Ltd.
- Indiana
  - South Bend, Indiana, Forenede Stater, 46635
    - Digestive Research Alliance of Michiana
- Iowa
  - Iowa City, Iowa, Forenede Stater, 52242
    - University of Iowa Hospitals and Clinics
- Kansas
  - El Dorado, Kansas, Forenede Stater, 67042
    - Alliance for Multispecialty Research, LLC
  - Shawnee Mission, Kansas, Forenede Stater, 66217
    - West Glen Gastrointestinal Consultants, P.A.
  - Wichita, Kansas, Forenede Stater, 67226
    - Kansas Gastroenterology, LLC
  - Wichita, Kansas, Forenede Stater, 67205
    - Alliance for Multispecialty Research-Wichita West
- Kentucky
  - Crestview Hills, Kentucky, Forenede Stater, 41017
    - Tri-State Gastroenterology Associates
  - Louisville, Kentucky, Forenede Stater, 40206
    - Robley Rex VA Medical Center
  - Louisville, Kentucky, Forenede Stater, 40202
    - University of Louisville Research Foundation
- Louisiana
  - Covington, Louisiana, Forenede Stater, 70433
    - Northlake Gastroenterology Associates
  - Hammond, Louisiana, Forenede Stater, 70403
    - Northlake Gastroenterology Associates
  - Houma, Louisiana, Forenede Stater, 70360
    - CroNOLA LLC
  - Lafayette, Louisiana, Forenede Stater, 70503
    - Gastroclinic
  - Lake Charles, Louisiana, Forenede Stater, 70601
    - Clinical Trials of SWLA, LLC
  - Monroe, Louisiana, Forenede Stater, 71201
    - Delta Research Partners
  - Shreveport, Louisiana, Forenede Stater, 71105
    - Louisiana Research Center, LLC
- Maryland
  - Columbia, Maryland, Forenede Stater, 21045
    - Gastro Center of Maryland
  - Elkridge, Maryland, Forenede Stater, 21075
    - Centennial Medical Group
  - Frederick, Maryland, Forenede Stater, 21701
    - Frederick Gastroenterology Associates
  - Greenbelt, Maryland, Forenede Stater, 20770
    - Mid-Atlantic GI Research
  - Rockville, Maryland, Forenede Stater, 20854
    - Meridian Clinical Research
- Massachusetts
  - Chelmsford, Massachusetts, Forenede Stater, 01824
    - Digestive Health Specialists
  - South Weymouth, Massachusetts, Forenede Stater, 02190
    - South Suburban Gastroenterology
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48109
    - University of Michigan
  - Rochester Hills, Michigan, Forenede Stater, 48307
    - Onyx Clinical Research
  - Saginaw, Michigan, Forenede Stater, 48602
    - Covenant HealthCare
  - Southfield, Michigan, Forenede Stater, 48034
    - Revive Research Institute, LLC
  - Troy, Michigan, Forenede Stater, 48098
    - Clinical Research Institute of Michigan, LLC
- Minnesota
  - Eagan, Minnesota, Forenede Stater, 55122
    - Curebase
- Mississippi
  - Columbus, Mississippi, Forenede Stater, 39705
    - Gastroenterology Associates of Mississippi
  - Jackson, Mississippi, Forenede Stater, 39216
    - Southern Therapy and Advanced Research
  - Ridgeland, Mississippi, Forenede Stater, 39157
    - Quinn Healthcare
- Missouri
  - Chesterfield, Missouri, Forenede Stater, 63005
    - Clinical Research Professionals, LLC
  - Saint Joseph, Missouri, Forenede Stater, 64057
    - Digestive Health Specialists, LLC
  - Saint Louis, Missouri, Forenede Stater, 63141
    - Sundance Clinical Research
  - Saint Louis, Missouri, Forenede Stater, 63104
    - Saint Louis University GI & Hepatology Research Unit
  - Saint Louis, Missouri, Forenede Stater, 63110
    - Washington University School of Medicine Gastroenterology
- Nebraska
  - Elkhorn, Nebraska, Forenede Stater, 68022
    - Skyline Medical Center, PC/CCT Research
  - Omaha, Nebraska, Forenede Stater, 68130
    - Midwest Regional Health Services, LLC/CCT Research
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89109
    - Excel Clinical Research
  - Las Vegas, Nevada, Forenede Stater, 89148
    - Wr-Crcn, Llc
  - Reno, Nevada, Forenede Stater, 89511
    - Advanced Research Institute
  - Reno, Nevada, Forenede Stater, 89502
    - Gastroenterology Consultants
  - Reno, Nevada, Forenede Stater, 89521
    - Gastroenterology Consultants
- New Jersey
  - Berlin, New Jersey, Forenede Stater, 08009
    - Hassman Research Institute
  - Brick, New Jersey, Forenede Stater, 08724
    - Allied Health Clinical Research Organization, LLC
  - Clifton, New Jersey, Forenede Stater, 07013
    - Gastroenterology Associates Of New Jersey
  - Florham Park, New Jersey, Forenede Stater, 07932
    - AIG Digestive Disease Research
  - Freehold, New Jersey, Forenede Stater, 07728
    - Allied Health Clinical Research Organization, LLC
  - Hackensack, New Jersey, Forenede Stater, 07601
    - Hackensack Digestive Disease Associates
  - Hillsborough, New Jersey, Forenede Stater, 08844
    - Digestive Healthcare Center
  - Jackson, New Jersey, Forenede Stater, 08527
    - Allied Health Clinical Research Organization
  - Montclair, New Jersey, Forenede Stater, 07042
    - Gastroenterology Associates Of New Jersey
  - Ocean City, New Jersey, Forenede Stater, 07712
    - Dr. Howard N. Guss and Dr. Gagan Beri
  - Ridgewood, New Jersey, Forenede Stater, 07450
    - Gastroenterology Associates Of New Jersey
  - Teaneck, New Jersey, Forenede Stater, 07666
    - Teaneck Gastroenterology Associates
  - Union, New Jersey, Forenede Stater, 07083
    - Advanced Gastroenterology Group
  - Wayne, New Jersey, Forenede Stater, 07470
    - Gastroenterology Associates Of New Jersey
  - Wayne, New Jersey, Forenede Stater, 07470
    - North Jersey Gastroenterology
  - Woodland Park, New Jersey, Forenede Stater, 07424
    - Gastroenterology Associates Of New Jersey
- New Mexico
  - Albuquerque, New Mexico, Forenede Stater, 87108
    - Lovelace Scientific Resources, Inc.
- New York
  - Brooklyn, New York, Forenede Stater, 11235
    - NY Scientific
  - Brooklyn, New York, Forenede Stater, 11234
    - Sam Moskowitz, MD
  - Camillus, New York, Forenede Stater, 13031
    - Associated Gastroenterologists of Central New York, Camillus
  - East Syracuse, New York, Forenede Stater, 13057
    - Associated Gastroenterology of Central New York
  - Fayetteville, New York, Forenede Stater, 13066
    - Associated Gastroenterologists of Central New York
  - Fresh Meadows, New York, Forenede Stater, 11366
    - Intercity Gastroenterology
  - Lawrence, New York, Forenede Stater, 11559
    - South Island Gastro
  - Manorville, New York, Forenede Stater, 11949
    - East End Gastroenterology & Hepatology
  - New City, New York, Forenede Stater, 10956
    - Gastrointestinal Associates of Rockland
  - Richmond Hill, New York, Forenede Stater, 11419
    - Smart Medical Research
  - Syracuse, New York, Forenede Stater, 13210
    - Syracuse Gastro Associates
  - Utica, New York, Forenede Stater, 13502
    - Digestive Disease Medicine of Central New York
  - Valley Stream, New York, Forenede Stater, 11581
    - GastroCare LI
  - Wantagh, New York, Forenede Stater, 11793
    - Gastrointestinal Specs Lng Is
  - West Nyack, New York, Forenede Stater, 10994
    - Eric L. Tatar, MD
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28801
    - Digestive Health Partners
  - Cary, North Carolina, Forenede Stater, 27518
    - Cary Gastro Associates
  - Chapel Hill, North Carolina, Forenede Stater, 27599
    - UNC Division of Gastroenterology and Hepatology
  - Charlotte, North Carolina, Forenede Stater, 28215
    - Carolinas Research Center
  - Charlotte, North Carolina, Forenede Stater, 28207
    - Charlotte Gastroenterology & Hepatology, PLLC
  - Charlotte, North Carolina, Forenede Stater, 28210
    - Javara Research
  - Charlotte, North Carolina, Forenede Stater, 28210
    - Carolina Digestive Health Associates, PA
  - Concord, North Carolina, Forenede Stater, 28027
    - Northeast GI Research Division
  - Concord, North Carolina, Forenede Stater, 28025
    - Carolina Digestive Health Associates, PA
  - Fayetteville, North Carolina, Forenede Stater, 28304
    - Coastal Research Institute, LLC
  - Greensboro, North Carolina, Forenede Stater, 27408
    - Medication Management LLC
  - Pinehurst, North Carolina, Forenede Stater, 28374
    - Pinehurst Medical Clinic
  - Raleigh, North Carolina, Forenede Stater, 27609
    - PMG Research of Raleigh
  - Raleigh, North Carolina, Forenede Stater, 27607
    - Carolina's GI Research, LLC
  - Rocky Mount, North Carolina, Forenede Stater, 27804
    - Boice Willis Clinic, PA
  - Salisbury, North Carolina, Forenede Stater, 28144
    - PMG Research of Salisbury, LLC
  - Statesville, North Carolina, Forenede Stater, 28625
    - Piedmont HealthCare, PA
  - Wilmington, North Carolina, Forenede Stater, 28403
    - Trial Management Associates, LLC
  - Wilmington, North Carolina, Forenede Stater, 28401
    - Wilmington Health
  - Winston-Salem, North Carolina, Forenede Stater, 27103
    - PMG Research of Winston
- North Dakota
  - Fargo, North Dakota, Forenede Stater, 58104
    - Plains Clinical Research Center, LLC
  - Fargo, North Dakota, Forenede Stater, 58104
    - Lillestol Research, LLC
- Ohio
  - Beachwood, Ohio, Forenede Stater, 44122
    - Gastroenterology Associates of Cleveland
  - Beavercreek, Ohio, Forenede Stater, 45440
    - Dayton Gastroenterology, Inc.
  - Beavercreek, Ohio, Forenede Stater, 45440
    - Dayton Gastroenterology
  - Cincinnati, Ohio, Forenede Stater, 45267
    - University of Cincinnati
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Gastro Health Research
  - Columbus, Ohio, Forenede Stater, 43213
    - ClinOhio Research Services
  - Dayton, Ohio, Forenede Stater, 45432
    - META Medical Research Institute
  - Dayton, Ohio, Forenede Stater, 45417
    - Advance Clinical Research
  - Mentor, Ohio, Forenede Stater, 44060
    - Great Lakes Gastroenterology
  - Springboro, Ohio, Forenede Stater, 45066
    - DSI Research, LLC
  - Toledo, Ohio, Forenede Stater, 43606
    - University of Toledo Internal Medicine Clinic
  - Warren, Ohio, Forenede Stater, 44484
    - Avamar Gastroenterology and Center
  - Westlake, Ohio, Forenede Stater, 44145
    - Northshore Gastroenterology & Endoscopy Center
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73112
    - Digestive Disease Specialists, Inc
  - Tulsa, Oklahoma, Forenede Stater, 74104
    - Options Health Research, LLC
- Oregon
  - Portland, Oregon, Forenede Stater, 97219
    - Fanno Creek Group
  - Portland, Oregon, Forenede Stater, 97220
    - The Oregon Clinic - Gastroenterology East
- Pennsylvania
  - Allentown, Pennsylvania, Forenede Stater, 18104
    - Eastern Pennsylvania GI & Liver Specialists
  - Altoona, Pennsylvania, Forenede Stater, 16602
    - US Digestive Health at Blair
  - Beaver Falls, Pennsylvania, Forenede Stater, 15010
    - Valley Gastroenterology Associates
  - Camp Hill, Pennsylvania, Forenede Stater, 17011
    - Susquehanna Research Group, LLC
  - Harrisburg, Pennsylvania, Forenede Stater, 17110
    - Susquehanna Research Group
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Perelman Center for Advanced Medicine
  - Philadelphia, Pennsylvania, Forenede Stater, 19141
    - Einstein Medical Center Department of Digestive Disease and Transplantation
  - Uniontown, Pennsylvania, Forenede Stater, 15401
    - Frontier Clinical Research, LLC
- Rhode Island
  - Cranston, Rhode Island, Forenede Stater, 02920
    - GIMED Associates, Inc.
  - Narragansett, Rhode Island, Forenede Stater, 02882
    - GIMED Associates, Inc.
- South Carolina
  - Greenwood, South Carolina, Forenede Stater, 29646
    - Digestive Disease Research Center
  - Mount Pleasant, South Carolina, Forenede Stater, 29464
    - Coastal Carolina Research Center
  - North Charleston, South Carolina, Forenede Stater, 29406
    - Southeast Medical Research/Elms Research
  - Orangeburg, South Carolina, Forenede Stater, 29118
    - South Carolina Clinical Research LLC
  - Summerville, South Carolina, Forenede Stater, 29486
    - PPCP Division of Gastroenterology LLC
  - West Columbia, South Carolina, Forenede Stater, 29169
    - Invocare Medical Research & Healthcare Center
- Tennessee
  - Austin, Tennessee, Forenede Stater, 78738
    - Elligo Clinical Research Center
  - Chattanooga, Tennessee, Forenede Stater, 37421
    - WR-ClinSearch, LLC
  - Chattanooga, Tennessee, Forenede Stater, 37403
    - Erlanger Health Clinical Resarch
  - Germantown, Tennessee, Forenede Stater, 38138
    - Gastro One
  - Jackson, Tennessee, Forenede Stater, 38305
    - The Jackson Clinic
  - Jackson, Tennessee, Forenede Stater, 38305
    - The Jackson Clinic, PA
  - Jackson, Tennessee, Forenede Stater, 38305
    - Helios Clinical Research lLC
  - Johnson City, Tennessee, Forenede Stater, 37604
    - East Tennessee Research Institute
  - Kingsport, Tennessee, Forenede Stater, 37663
    - Tri-Cities Gastroenterology
  - Knoxville, Tennessee, Forenede Stater, 37909
    - Gastrointestinal Associates, P.C.
  - Nashville, Tennessee, Forenede Stater, 37212
    - Vanderbilt University Medical Center
  - Union City, Tennessee, Forenede Stater, 38261
    - Advanced Gastroenterology
- Texas
  - Cypress, Texas, Forenede Stater, 77429
    - Allied Digestive Disease Center
  - Cypress, Texas, Forenede Stater, 77429
    - Northside Gastroenterology Associates
  - Cypress, Texas, Forenede Stater, 77429
    - Uma Mohan MD PA
  - El Paso, Texas, Forenede Stater, 79912
    - El Paso Integrated Physicians Group, P.A.
  - Houston, Texas, Forenede Stater, 77030
    - University of Texas MD Anderson Cancer Center
  - Houston, Texas, Forenede Stater, 77074
    - Houston Digestive Diseases Consultants
  - Houston, Texas, Forenede Stater, 77024
    - Digestive Health Associates
  - Houston, Texas, Forenede Stater, 77055
    - Biopharma Informatic
  - Houston, Texas, Forenede Stater, 77057
    - Diversified Medical Practices
  - Houston, Texas, Forenede Stater, 77084
    - Memorial Hermann Surgery Center
  - Hurst, Texas, Forenede Stater, 76054
    - Protenium Clinical Research Inc.
  - McAllen, Texas, Forenede Stater, 78503
    - Biopharma Informatic
  - Pasadena, Texas, Forenede Stater, 77504
    - Gastroenterology Consultants, P.A.
  - San Antonio, Texas, Forenede Stater, 78212
    - Clinical Associates in Research Therapeutics of America
  - Shenandoah, Texas, Forenede Stater, 77384
    - Gastroenterology Partners of North Houston
  - Spring, Texas, Forenede Stater, 77386
    - Texas Gastroenterology Associates/A1 Clinical Network
  - Sugar Land, Texas, Forenede Stater, 77479
    - Gastroenterology Associates of Texas, PA
  - Tomball, Texas, Forenede Stater, 77375
    - Texas Gastro Consultants
  - Wichita Falls, Texas, Forenede Stater, 76301
    - Digestive Health Research of North Texas
- Utah
  - Bountiful, Utah, Forenede Stater, 84010
    - Progressive Clinical Research
  - Ogden, Utah, Forenede Stater, 84405
    - Advanced Research Institute
  - Sandy, Utah, Forenede Stater, 84092
    - Advanced Research Institute Granite Peaks Gastroenterology
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22911
    - Charlottesville Medical Research
  - Chesapeake, Virginia, Forenede Stater, 23320
    - Gastroenterology Associates of Tidewater
  - Fairfax, Virginia, Forenede Stater, 22031
    - Verity Research
  - Lynchburg, Virginia, Forenede Stater, 24502
    - Blue Ridge Medical Research
  - Reston, Virginia, Forenede Stater, 20191
    - The Gastroenterology Group
  - Richmond, Virginia, Forenede Stater, 23236
    - GI Select Health Research, LLC
  - Williamsburg, Virginia, Forenede Stater, 23188
    - Tidewater Physicians Multispecialty Group Clinical Research
- Washington
  - Bellevue, Washington, Forenede Stater, 98004
    - Washington Gastroenterology
  - Everett, Washington, Forenede Stater, 98208
    - Western Washington Medical Group, Inc
  - Spokane, Washington, Forenede Stater, 99202
    - Velocity Clinical Research
- Wisconsin
  - Manitowoc, Wisconsin, Forenede Stater, 54221
    - Holy Family Memorial, Inc
  - Milwaukee, Wisconsin, Forenede Stater, 53226
    - Medical College of Wisconsin
  - Stevens Point, Wisconsin, Forenede Stater, 54482
    - GI Associates
  - Wausau, Wisconsin, Forenede Stater, 54401
    - GI Associates

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

45 år til 84 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Enkelt kohorte af patienter i alderen mellem 45 og 84 år, uden kendte højrisikotræk, gennemgår rutinemæssig screening for kolorektal cancer som standardbehandling.

Beskrivelse

Inklusionskriterier:

Forsøgspersoner i alderen 45-84 år på tidspunktet for samtykke
Beregnet til at gennemgå screening koloskopi
Anses af en læge eller sundhedsudbyder som værende af 'gennemsnitlig risiko' for CRC
Villig til at give samtykke til at tage blodprøver før tarmpræparation, inden den gennemgår koloskopi inden for 60 dage efter datoen for undersøgelsen af blodprøven
Vil gerne give samtykke til opfølgning i to år i henhold til protokol

Ekskluderingskriterier:

Undergår koloskopi til undersøgelse af symptomer
Har gennemgået koloskopi inden for de foregående 9 år
Positivt FIT/FOBT resultat inden for de foregående 6 måneder
Har gennemført Cologuard eller Epi proColon test inden for de foregående 3 år
Historie om tyktarmskræft
Anamnese med enhver malignitet (patienter, der har gennemgået kirurgisk fjernelse af pladecellekræft i huden, kan tilmeldes, forudsat at proceduren blev afsluttet mindst 12 måneder før datoen for afgivelse af informeret samtykke til undersøgelsen)
Kendt diagnose af inflammatorisk tarmsygdom
Tager i øjeblikket anti-neoplastiske eller sygdomsmodificerende anti-reumatiske lægemidler (DMARDs)
Positiv familiehistorie med tyktarmskræft, defineret som at have en eller flere førstegradsslægtninge (forælder, søskende eller barn) med CRC i enhver alder
Kendt arvelig risiko for kolorektal cancer (f.eks. Lynch syndrom eller arvelig non-polypose CRC [HNPCC], eller familiær adenomatøs polypose [FAP])
Ethvert større fysisk traume (f.eks. afbrydelse af væv, kirurgi, organtransplantation, blodprodukttransfusion) inden for de 30 dage, der går op til afgivelsen af informeret samtykke
Kendt medicinsk tilstand, som efter investigators mening bør udelukke optagelse i undersøgelsen
Deltagelse i en klinisk forskningsundersøgelse, hvor en eksperimentel medicin er blevet administreret eller kan administreres inden for de 30 dage, der går forud for at give informeret samtykke eller kan administreres gennem 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	Foranstaltningsbeskrivelse	Tidsramme
Følsomhed ved påvisning af kolorektal cancer Tidsramme: 60 dage	Følsomhed ved påvisning af kolorektal cancer	60 dage
Specificitet af avanceret neoplasi detektion Tidsramme: 60 dage	Specificitet af avanceret neoplasi detektion	60 dage

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Positiv prædiktiv værdi af påvisning af kolorektal cancer Tidsramme: 60 dage	Positiv prædiktiv værdi af påvisning af kolorektal cancer	60 dage
Negativ prædiktiv værdi af påvisning af kolorektal cancer Tidsramme: 60 dage	Negativ prædiktiv værdi af påvisning af kolorektal cancer	60 dage
Sensitivitet og specificitet af avanceret adenomdetektion Tidsramme: 60 dage	Sensitivitet og specificitet af avanceret adenomdetektion	60 dage

Samarbejdspartnere og efterforskere

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

Sponsor

Guardant Health, Inc.

Samarbejdspartnere

Premier Research Group plc

Efterforskere

Ledende efterforsker: Craig Eagle, MD, Guardant Health, 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)

8. oktober 2019

Primær færdiggørelse (Anslået)

1. juni 2024

Studieafslutning (Anslået)

31. december 2025

Datoer for studieregistrering

Først indsendt

21. oktober 2019

Først indsendt, der opfyldte QC-kriterier

21. oktober 2019

Først opslået (Faktiske)

23. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. april 2024

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2024

Sidst verificeret

1. april 2024

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

02-GI-002

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 Kolorektal cancer

University of Arkansas

Aktiv, ikke rekrutterende

Virkningen af det forbedrede restitution efter kirurgi-system til kolorektal kirurgi

Colorectal cancer og inflammatorisk tarmsygdom

Forenede Stater
University Health Network, Toronto
AstraZeneca

Aktiv, ikke rekrutterende

Kurvkombinationsundersøgelse af hæmmere af DNA-skaderespons, angiogenese og programmeret dødsligand 1 hos patienter med avancerede solide tumorer (DAPPER)

Adenocarcinom i bugspytkirtlen | Leiomyosarkom | Mismatch Reparation Proficient Colorectal Cancer

Canada
Tianjin Medical University Cancer Institute and...

Rekruttering

PD-1-hæmmer kombineret med Bevacizumab og FOLFIRI-regimen i andenlinjebehandlingen af avanceret kolorektal cancer

MSI-H Advanced Colorectal Cancer

Kina
Bristol-Myers Squibb

Aktiv, ikke rekrutterende

En undersøgelse af Nivolumab alene eller Nivolumab kombinationsterapi ved tyktarmskræft, der er vendt tilbage eller har spredt sig (CheckMate142)

Mikrosatellit stabil kolorektal cancer | Mismatch Reparation Proficient Colorectal Cancer | Mikrosatellit ustabil kolorektal cancer | Mismatch Reparation Manglende tyktarmskræft

Forenede Stater, Australien, Belgien, Canada, Irland, Italien, Spanien, Frankrig
Syndax Pharmaceuticals
Merck Sharp & Dohme LLC

Afsluttet

Ph1b/2 dosis-eskaleringsundersøgelse af entinostat med Pembrolizumab i NSCLC med ekspansionskohorter i NSCLC, melanom og kolorektal cancer

Melanom | Ikke-småcellet lungekræft | Mismatch Reparation-Proficient Colorectal Cancer

Forenede Stater

Evaluering af ctDNA LUNAR-testen i en gennemsnitlig patientscreeningsepisode (ECLIPSE)

Studieoversigt

Status

Betingelser

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Prøveudtagningsmetode

Studiebefolkning

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Kliniske forsøg med Kolorektal cancer

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Canada

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer