Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Klinisk validering av en optimalisert multi-target avførings-DNA (Mt-sDNA 2.0)-test, for screening av kolorektal kreft BLUE-C"
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Studietype
Registrering (Faktiske)
Registrering
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Marla Kuleszynski
- Telefonnummer: 608-400-3569
- E-post: mkuleszynski@exactsciences.com
Studer Kontakt Backup
- Navn: Dania Brooks
- Telefonnummer: 608-293-3437
- E-post: dbrooks@exactsciences.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Forente stater, 35215
- Parkway Medical Center
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Birmingham, Alabama, Forente stater, 35243
- Summit Internal Medicine, PC
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Cullman, Alabama, Forente stater, 35055
- Cullman Clinical Trials
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Dothan, Alabama, Forente stater, 36301
- Digestive Health Specialists Of The Southeast
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Foley, Alabama, Forente stater, 36535
- G & L Research
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Huntsville, Alabama, Forente stater, 35801
- Medical Affiliated Research Center
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Mobile, Alabama, Forente stater, 36608
- East View Medical Research, LLC
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Tuscaloosa, Alabama, Forente stater, 35406
- GI Associates of West Alabama, P.C
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Arizona
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Phoenix, Arizona, Forente stater, 85054
- Mayo Clinic - AZ
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Tucson, Arizona, Forente stater, 85712
- Del Sol Research Management, LLC
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Tucson, Arizona, Forente stater, 85723
- Southern Arizona VA Health Care System (SAVAHCS)
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Arkansas
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Little Rock, Arkansas, Forente stater, 72204
- Lynn Institute of the Ozarks
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Little Rock, Arkansas, Forente stater, 72212
- Applied Research Center of Arkansas
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North Little Rock, Arkansas, Forente stater, 72117
- Arkansas Gastroenterology, P.A.
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California
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Camarillo, California, Forente stater, 93012
- Fomat Medical Research
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Canoga Park, California, Forente stater, 91304
- Alliance Research Institute
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Chula Vista, California, Forente stater, 91910
- GW Research Inc
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Garden Grove, California, Forente stater, 92840
- Paragon Rx Clinical, Inc.
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Irvine, California, Forente stater, 92618
- United Medical Doctors
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Laguna Hills, California, Forente stater, 92656
- Prime Care Clinical Research Center
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Lancaster, California, Forente stater, 93534
- Gastro Care Institute
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Mission Hills, California, Forente stater, 91345
- Facey Medical Foundation
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Orange, California, Forente stater, 92868
- Knowledge Research Center
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Palm Springs, California, Forente stater, 92262
- Desert Oasis Healthcare Medical Group
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Palo Alto, California, Forente stater, 34304
- Palo Alto Veterans Institute for Research
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San Diego, California, Forente stater, 92103
- SDG Clinical Research
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San Jose, California, Forente stater, 95116
- San Jose Gastroenterology
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Santa Ana, California, Forente stater, 92703
- Paragon Rx Clinical, Inc. - Santa Ana
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Santa Barbara, California, Forente stater, 93105
- Sansum Clinic
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Sherman Oaks, California, Forente stater, 91403
- Unison Clinical Trials
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Thousand Oaks, California, Forente stater, 91360
- Millennium Clinical Trials
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Upland, California, Forente stater, 91786
- Dream Team Clinical Research
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Colorado
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Golden, Colorado, Forente stater, 80401
- New West Physicians
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Connecticut
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Bridgeport, Connecticut, Forente stater, 06610
- Bridgeport Hospital
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Bridgeport, Connecticut, Forente stater, 06606
- Gastroenterology Associates of Fairfield County
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Bristol, Connecticut, Forente stater, 06010
- Connecticut Clinical Research Institute
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New Haven, Connecticut, Forente stater, 06519
- Yale University
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Florida
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Altamonte Springs, Florida, Forente stater, 32701
- Cornerstone Research Institute
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Fort Myers, Florida, Forente stater, 33907
- Vanguard Clinical Research
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Gainesville, Florida, Forente stater, 32607
- SIMED Health Research
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Jacksonville, Florida, Forente stater, 32205
- Westside Center of Clinical Research
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Jacksonville, Florida, Forente stater, 32206
- Shands Jacksonville Medical Center, Inc - University of Florida Health
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Jupiter, Florida, Forente stater, 33458
- Health Awareness, Inc.
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Lake City, Florida, Forente stater, 32055
- Wr-Msra, Llc
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Lighthouse Point, Florida, Forente stater, 33064
- Alliance Medical Research
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Miami, Florida, Forente stater, 33156
- Research Associates of South Florida, LLC
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Miami, Florida, Forente stater, 33144
- Next Phase Research Alliance
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Miami, Florida, Forente stater, 33135
- Suncoast Research Group, LLC
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Miami, Florida, Forente stater, 33176
- Gastro Health Research
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Naples, Florida, Forente stater, 34102
- Gastroenterology Group of Naples
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Ocala, Florida, Forente stater, 34471
- Sarkis Clinical Trials
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Palmetto Bay, Florida, Forente stater, 33157
- IMIC, Inc.
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Plant City, Florida, Forente stater, 33563
- Family Medical Specialists of Florida, PLC
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Saint Petersburg, Florida, Forente stater, 33711
- Alternative Solutions, LLC
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Sunrise, Florida, Forente stater, 33351
- Precision Clinical Research, LLC
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Tampa, Florida, Forente stater, 33614
- Clinical Trials of Tampa
-
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Georgia
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Athens, Georgia, Forente stater, 30607
- Summit Clinical Research, LLC
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Augusta, Georgia, Forente stater, 30912
- Augusta University
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Decatur, Georgia, Forente stater, 30033
- Atlanta Center for Gastroenterology, P.C.
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Morrow, Georgia, Forente stater, 30260
- Infinite Clinical Trials
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Idaho
-
Idaho Falls, Idaho, Forente stater, 83404
- Grand Teton Research Group
-
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Illinois
-
Champaign, Illinois, Forente stater, 61882
- Christie Clinic
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Chicago, Illinois, Forente stater, 60612
- Rush University Medical Center
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Downers Grove, Illinois, Forente stater, 60515
- GI Partners of IL / Avicenna
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Hines, Illinois, Forente stater, 60141
- Edward Hines Jr. VA Hospital
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Oak Lawn, Illinois, Forente stater, 60453
- Southwest Gastroenterology
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Indiana
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Evansville, Indiana, Forente stater, 47713
- Deaconess Clinic, Inc.
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Newburgh, Indiana, Forente stater, 47630
- Deaconess Clinic, Inc.
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South Bend, Indiana, Forente stater, 46617
- The South Bend Clinic
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Iowa
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Ames, Iowa, Forente stater, 50010
- PMG Research
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Iowa City, Iowa, Forente stater, 52242
- University of Iowa
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West Des Moines, Iowa, Forente stater, 50266
- The Iowa Clinic, P.C.
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Kansas
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Galena, Kansas, Forente stater, 66739
- Digestive Health Center of the Four States, LLC
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Hutchinson, Kansas, Forente stater, 67502
- Hutchinson Clinic
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Wichita, Kansas, Forente stater, 67214
- Ascension Via Christi Hospitals Wichita, Inc
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Kentucky
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Edgewood, Kentucky, Forente stater, 41017
- St. Elizabeth Healthcare
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Louisiana
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Eunice, Louisiana, Forente stater, 70535
- Horizon Research Group of Opelousas, LLC
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Houma, Louisiana, Forente stater, 70360
- Houma Digestive Health Specialists-CroNOLA
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Lafayette, Louisiana, Forente stater, 70503
- Combined Gastro Research. LLC
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Lake Charles, Louisiana, Forente stater, 70601
- Clinical Trials of SWLA, LLC
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Metairie, Louisiana, Forente stater, 70006
- New Orleans Research Institute
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Metairie, Louisiana, Forente stater, 70006
- Clinical Trials Management, LLC
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Monroe, Louisiana, Forente stater, 71201
- Delta Research Partners
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Shreveport, Louisiana, Forente stater, 71105
- Louisiana Research Center; Gastrointestinal Associates
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West Monroe, Louisiana, Forente stater, 71291
- Clinical Trials of America, LLC
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Maryland
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Annapolis, Maryland, Forente stater, 21401
- Gastro Health Research
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Chevy Chase, Maryland, Forente stater, 20815
- Chevy Chase Clinical Research
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Elkridge, Maryland, Forente stater, 21075
- Centennial Medical Group
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forente stater, 02215
- Beth Israel Deaconess Medical Center - Harvard
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Cambridge, Massachusetts, Forente stater, 02139
- IQVIA RDS, Inc.
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Chelmsford, Massachusetts, Forente stater, 01824
- Digestive Health Specialists, PC
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Fall River, Massachusetts, Forente stater, 02721
- NECCR PrimaCare Research, LLC
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Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts - Worcester
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan
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Troy, Michigan, Forente stater, 48085
- Oakland Medical Research Center
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Troy, Michigan, Forente stater, 48098
- Center for Digestive Health Research
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Troy, Michigan, Forente stater, 48085
- Oakland Medical Research
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic
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Mississippi
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Jackson, Mississippi, Forente stater, 39216
- Southern Therapy and Advanced Research LLC (STAR)
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Missouri
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Chesterfield, Missouri, Forente stater, 63005
- Clinical Research Professionals
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Saint Louis, Missouri, Forente stater, 63141
- Sundance Clinical Research, LLC
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Nebraska
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Fremont, Nebraska, Forente stater, 68025
- Methodist Physicians Clinic / CCT Research
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Omaha, Nebraska, Forente stater, 68124
- CHI Nebraska
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Nevada
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Las Vegas, Nevada, Forente stater, 89121
- Clinical Research of South Nevada
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Las Vegas, Nevada, Forente stater, 89102
- University of Nevada, Las Vegas
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Reno, Nevada, Forente stater, 89511
- Digestive Health Associates
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New Jersey
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Egg Harbor Township, New Jersey, Forente stater, 08234
- AGA Clinical Research Associates, LLC
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West Long Branch, New Jersey, Forente stater, 07728
- Allied Health Clinical Research Organization, LLC
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New York
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Binghamton, New York, Forente stater, 13903
- United Health Services Hospitals, Inc.
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Brooklyn, New York, Forente stater, 11209
- VA NY Harbor HCS- Brooklyn Campus
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Flushing, New York, Forente stater, 11354
- Sing Chan, MD
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New Windsor, New York, Forente stater, 12553
- Mid Hudson Medical Research, PLLC
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New York, New York, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai
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North Massapequa, New York, Forente stater, 11758
- DiGiovanna Institute for Medical Education & Research
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North Carolina
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Asheville, North Carolina, Forente stater, 28801
- Digestive Health Partners, PA
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Chapel Hill, North Carolina, Forente stater, 27599
- University of North Carolina at Chapel Hill
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Charlotte, North Carolina, Forente stater, 28210
- Javara
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Charlotte, North Carolina, Forente stater, 28207
- Atrium Health Department of Family Medicine Research
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Fayetteville, North Carolina, Forente stater, 28304
- Coastal Research Institute, LLC
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Greensboro, North Carolina, Forente stater, 27408
- Medication Management LLC
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High Point, North Carolina, Forente stater, 27262
- Peters Medical Research
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Mount Airy, North Carolina, Forente stater, 27030
- Clinical Trials of America, LLC
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New Bern, North Carolina, Forente stater, 28562
- Coastal Carolina Health Care, P.A
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Wilmington, North Carolina, Forente stater, 28403
- Trial Management Associates, LLC
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North Dakota
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Fargo, North Dakota, Forente stater, 58104
- Plains Clinical Research Center, LLC
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Fargo, North Dakota, Forente stater, 58104
- Lillestol Research, LLC
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Ohio
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Beachwood, Ohio, Forente stater, 44122
- Great Lakes Medical Research LLC
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Cincinnati, Ohio, Forente stater, 45224
- Hightop Medical Research Center
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Cincinnati, Ohio, Forente stater, 45219
- Gastro Health Research
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Cleveland Medical Center
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Dayton, Ohio, Forente stater, 45409
- Dayton Clinical Research
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Dayton, Ohio, Forente stater, 45432
- Meta Medical Research Institute, LLC
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Mentor, Ohio, Forente stater, 44060
- Great Lakes Gastroenterology Research, LLC
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Middleburg Heights, Ohio, Forente stater, 44130
- Paramount Medical Research and Consulting, Llc
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Westlake, Ohio, Forente stater, 44145
- NorthShore Gastroenterology Research, LLC
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Wooster, Ohio, Forente stater, 44691
- Comprehensive Internal Medicine, Inc
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Oklahoma
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Norman, Oklahoma, Forente stater, 73069
- Alliance for Multispecialty Research, LLC
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Oklahoma City, Oklahoma, Forente stater, 73102
- SSM Health Medical Group/Hightower Clinical
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Tulsa, Oklahoma, Forente stater, 74104
- Options Health Research, LLC
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Pennsylvania
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Harrisburg, Pennsylvania, Forente stater, 17110
- Great Lakes Medical Research, LLC
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Johnstown, Pennsylvania, Forente stater, 15905
- Richard M. Kastelic, M.D., and Associates, P.C.
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Lancaster, Pennsylvania, Forente stater, 17601
- Regional GI
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University Philadelphia
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Pottsville, Pennsylvania, Forente stater, 17901
- Care Access Research, Pottsville
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South Carolina
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Charleston, South Carolina, Forente stater, 29412
- Pharmacorp Clinical Trials, Inc.
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Charleston, South Carolina, Forente stater, 29401
- Ralph H. Johnson VAMC
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West Columbia, South Carolina, Forente stater, 29169
- Invocare Medical Research & Healthcare Center
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Rapid City Medical Center, LLP
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37421
- WR-ClinSearch, LLC
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Germantown, Tennessee, Forente stater, 38138
- Gastro One
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Jackson, Tennessee, Forente stater, 38301
- The Jackson Clinic, PA
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Jackson, Tennessee, Forente stater, 38305
- The Jackson Clinic, PA
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Jackson, Tennessee, Forente stater, 38305
- Clinical Research Solutions, LLC - TN
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Kingsport, Tennessee, Forente stater, 37663
- Tri-Cities Gastroenterology
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Union City, Tennessee, Forente stater, 38261
- Great Lakes Medical Research, LLC
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Texas
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Austin, Texas, Forente stater, 78745
- ARC Clinical Research at William Cannon
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Austin, Texas, Forente stater, 78726
- ARC Clinical Research at Four Points
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Austin, Texas, Forente stater, 78738
- Elligo Health Research Inc
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Austin, Texas, Forente stater, 78748
- Avant Research Associates
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Dallas, Texas, Forente stater, 75211
- Mercy Family Clinic
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Dallas, Texas, Forente stater, 75235
- Dharma PA D/B/A Southwest Family Medicine Associates
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El Paso, Texas, Forente stater, 79905
- Texas Tech University Health Sciences Center El Paso
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Houston, Texas, Forente stater, 77030
- UT MD Anderson Cancer Center
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Houston, Texas, Forente stater, 77084
- Biopharma Informatic, LLC
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Houston, Texas, Forente stater, 77030
- Houston Digestive Disease
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Houston, Texas, Forente stater, 77087
- Fairway Medical Clinic
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Houston, Texas, Forente stater, 77505
- Digestive System Healthcare
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Lampasas, Texas, Forente stater, 76550
- Fmc Science, Llc
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McAllen, Texas, Forente stater, 78503
- Rio Grande Gastroenterology
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McKinney, Texas, Forente stater, 75071
- Wellness Clinical Research
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Pflugerville, Texas, Forente stater, 78660
- ARC Clinical Research at Kelly Lane
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Red Oak, Texas, Forente stater, 75154
- Epic Medical Research LLC
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San Antonio, Texas, Forente stater, 78229
- Gastroenterology Research of San Antonio
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San Antonio, Texas, Forente stater, 78212
- Clinical Associates in Research Therapeutics of America
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Sugar Land, Texas, Forente stater, 77479
- A & U Family Medicine
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Tomball, Texas, Forente stater, 77375
- Texas Gastro Consultants
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Utah
-
Bountiful, Utah, Forente stater, 84010
- Progressive Clinical Research, LLC
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Layton, Utah, Forente stater, 84041
- Tanner Clinic
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Ogden, Utah, Forente stater, 84405
- Advanced Research Institute
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Riverton, Utah, Forente stater, 84096
- Granger Medical Clinic
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Riverton, Utah, Forente stater, 84065
- Advanced Clinical Research
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Sandy, Utah, Forente stater, 84092
- Advanced Research Institute
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Virginia
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Lynchburg, Virginia, Forente stater, 24502
- Blue Ridge Medical Research
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Petersburg, Virginia, Forente stater, 23805
- Summit Clinical Research
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Richmond, Virginia, Forente stater, 23249
- Central Virginia VA Healthcare System
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Suffolk, Virginia, Forente stater, 23434
- Virginia Gastroenterology Institute
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Washington
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Seattle, Washington, Forente stater, 98101
- Benaroya Research Institute at Virginia Mason
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Spokane, Washington, Forente stater, 99202
- Spokane Gastroenterology
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Wenatchee, Washington, Forente stater, 98801
- Wentachee Valley Hospital
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West Virginia
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Huntington, West Virginia, Forente stater, 25701
- University Physicians and Surgeons, Inc.(Marshall Health)
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Wisconsin
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Madison, Wisconsin, Forente stater, 53215
- University of Wisconsin Hospital and Clinics
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Milwaukee, Wisconsin, Forente stater, 53215
- Wisconsin Center for Advanced Research
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inklusjonskriterier:
- Emnet er for tiden registrert i Exact Sciences Protocol 2019-01 BLUE-C.
- Forsøkspersonen er villig og i stand til å gi en blodprøve.
- Subjektet er villig og i stand til å signere informert samtykke.
Ekskluderingskriterier:
1. Forsøkspersonen har noen forutsetninger som etter etterforskerens mening bør utelukke deltakelse i studien.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Antall grupper / kohorter
Kohorter og intervensjoner
Gruppe / KohortGruppe / Kohort |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Emner påmeldt i 2019-01 BLUE-C
Emner vil være menn og kvinner, 40 år eller eldre, som melder seg på Exact Sciences Protocol 2019-01 BLUE-C.
Forsøkspersonene vil gi en blodprøve ved påmelding.
|
Forsøkspersoner som deltar i studien vil få tatt blod ved påmelding.
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Blodbaserte biomarkører assosiert med genetiske og epigenetiske endringer.
Tidsramme: Tidspunkt for blodprøvetaking (1 dag) ved påmelding
|
Tidspunkt for blodprøvetaking (1 dag) ved påmelding
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Etterforskere
Etterforskere
- Hovedetterforsker: Thomas Imperiale, MD, Indiana University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
Primær fullføring (Faktiske)
Primær fullføring
Studiet fullført (Faktiske)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- 2019-01B
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .