- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02889978
Den cirkulerende cellefri genomatlas-undersøgelse (CCGA)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- UHN Princess Margaret Cancer Centre
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Alabama
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Daphne, Alabama, Forenede Stater, 36526
- Southern Cancer Center, PC - Daphne
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Mobile, Alabama, Forenede Stater, 36607
- Southern Cancer Center, P.C. - Mobile Infirmary
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Mobile, Alabama, Forenede Stater, 36608
- Southern Cancer Center, PC - Mobile Airport
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Mobile, Alabama, Forenede Stater, 36608
- Southern Cancer Center, PC - Springhill Medical Center
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic - Arizona
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Arkansas
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Fort Smith, Arkansas, Forenede Stater, 72903
- Mercy Fort Smith
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California
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Santa Barbara, California, Forenede Stater, 93105
- Sansum Clinic - 540
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Santa Barbara, California, Forenede Stater, 93105
- Sansum Clinic- 317
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Solvang, California, Forenede Stater, 93463
- Sansum Clinic - Viborg
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Rocky Mountain Cancer Centers
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Boulder, Colorado, Forenede Stater, 80303
- Rocky Mountain Cancer Center
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Centennial, Colorado, Forenede Stater, 80112
- Rocky Mountain Cancer Centers
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Colorado Springs, Colorado, Forenede Stater, 80907
- Rocky Mountain Cancer Center
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Denver, Colorado, Forenede Stater, 80218
- Rocky Mountain Cancer Centers
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Denver, Colorado, Forenede Stater, 80220
- Rocky Mountain Cancer Centers
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Englewood, Colorado, Forenede Stater, 80113
- Rocky Mountain Cancer Centers
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Lakewood, Colorado, Forenede Stater, 80228
- Rocky Mountain Cancer Center
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Littleton, Colorado, Forenede Stater, 80120-4413
- Rocky Mountain Cancer Centers
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Lone Tree, Colorado, Forenede Stater, 80124
- Rocky Mountain Cancer Centers
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Longmont, Colorado, Forenede Stater, 80501
- Rocky Mountain Cancer Centers
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Pueblo, Colorado, Forenede Stater, 81008
- Rocky Mountain Cancer Center
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Thornton, Colorado, Forenede Stater, 80260
- Rocky Mountain Cancer Centers
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06102
- Hartford Healthcare Cancer Institute at Hartford Hospital
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New Britain, Connecticut, Forenede Stater, 06052
- Hartford New Britain
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Florida
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Coral Gables, Florida, Forenede Stater, 33146
- UMHC Lennar Foundation - Coral Gables
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Coral Springs, Florida, Forenede Stater, 33065
- UMHC Sylvester- Coral Springs
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Deerfield Beach, Florida, Forenede Stater, 33442
- University of Miami Sylvester at Deerfield Beach
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Hollywood, Florida, Forenede Stater, 33021
- University of Miami Sylvester at Hollywood
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic - Florida
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Kendall, Florida, Forenede Stater, 33176
- University of Miami Sylvester at Kendall
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Miami, Florida, Forenede Stater, 33136
- University of Miami Sylvester Comprehensive Cancer Center
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Ocala, Florida, Forenede Stater, 34471
- Florida Cancer Affiliates - Ocala
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Pensacola, Florida, Forenede Stater, 32503
- Woodlands Medical Specialists, PA
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Plantation, Florida, Forenede Stater, 33324
- University of Miami Sylvester at Plantation
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Illinois
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Arlington Heights, Illinois, Forenede Stater, 60005
- Illinois Cancer Specialists
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Niles, Illinois, Forenede Stater, 60714
- Illinois Cancer Specialists
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
- Baptist Health Lexington
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Louisville, Kentucky, Forenede Stater, 40207
- Baptist Health Louisville
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Paducah, Kentucky, Forenede Stater, 42003
- Baptist Health Paducah
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Maryland
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Bethesda, Maryland, Forenede Stater, 20817
- Maryland Oncology Hematology, P.A.
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Brandywine, Maryland, Forenede Stater, 20613
- Maryland Oncology Hematology, P.A.
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Clinton, Maryland, Forenede Stater, 20735
- Maryland Oncology Hematology, P.A.
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Columbia, Maryland, Forenede Stater, 21044
- Maryland Oncology Hematology, P.A.
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Rockville, Maryland, Forenede Stater, 20850
- Maryland Oncology Hematology, P.A.
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Silver Spring, Maryland, Forenede Stater, 20904
- Maryland Oncology Hematology, P.A.
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Dana-Farber Cancer Institute
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Burlington, Massachusetts, Forenede Stater, 01805
- Lahey Hospital & Medical Center
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Peabody, Massachusetts, Forenede Stater, 01960
- Lahey Hospital & Medical Center - Peabody
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Minnesota
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Minnesota Oncology Hematology, P.A. - Main
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Edina, Minnesota, Forenede Stater, 55435
- Minnesota Oncology Hematology, P.A. - Edina
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Minneapolis, Minnesota, Forenede Stater, 55404
- Minnesota Oncology Hematology, P.A. - Woodbury
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Rochester, Minnesota, Forenede Stater, 32224
- Mayo Clinic - Rochester
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Woodbury, Minnesota, Forenede Stater, 55125
- Minnesota Oncology Hematology, P.A. - Coon Rapids
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Missouri
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Joplin, Missouri, Forenede Stater, 64804
- Mercy Joplin
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Springfield, Missouri, Forenede Stater, 65804
- Mercy Research - Springfield
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New Jersey
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Basking Ridge, New Jersey, Forenede Stater, 07920
- Memorial Sloan Kettering - Basking Ridge
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Middletown, New Jersey, Forenede Stater, 07748
- Memorial Sloan Kettering, NY - Monmouth
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New York
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Albany, New York, Forenede Stater, 12206
- New York Oncology Hematology, P.C.
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Albany, New York, Forenede Stater, 12208
- New York Oncology Hematology, P.C.
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Binghamton, New York, Forenede Stater, 13905
- Broome Oncology, LLC
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Clifton Park, New York, Forenede Stater, 12065
- New York Oncology Hematology, P.C.
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Johnson City, New York, Forenede Stater, 13790
- Broome Oncology, LLC
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New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering - Rockville Center
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering, NY - Commack
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering, NY - West Harrison
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45202
- Oncology Hematology Care, Inc. - Reading Road
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Cincinnati, Ohio, Forenede Stater, 45211
- Oncology Hematology Care, Inc. - Fairfield
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Cincinnati, Ohio, Forenede Stater, 45219
- Christ Hospital Health Network - The Lindner Center Cancer Research Division
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Cincinnati, Ohio, Forenede Stater, 45230
- Oncology Hematology Care, Inc. - Mercy Health
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Cincinnati, Ohio, Forenede Stater, 45236
- Oncology Hematology Care, Inc. - E. Galbraith
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Cincinnati, Ohio, Forenede Stater, 45242
- Oncology Hematology Care, Inc. - Malsbary
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic
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Fairfield, Ohio, Forenede Stater, 45014
- Oncology Hematology Care, Inc. - Five Mile Road
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Oregon
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Portland, Oregon, Forenede Stater, 97201
- Oregon Health & Science University Knight Cancer Institute
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Portland, Oregon, Forenede Stater, 97213-2982
- Northwest Cancer Specialists, P.C. dba Compass Oncology
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Portland, Oregon, Forenede Stater, 97225
- Northwest Cancer Specialists, P.C. dba Compass Oncology
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Portland, Oregon, Forenede Stater, 97227
- Northwest Cancer Specialists, P.C. dba Compass Oncology
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Tualatin, Oregon, Forenede Stater, 97062
- Northwest Cancer Specialists, P.C. dba Compass Oncology
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Pennsylvania
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Allentown, Pennsylvania, Forenede Stater, 18101
- Lehigh Valley Hospital - Cedar Crest
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Cancer Center at Lehigh Valley Hospital - Muhlenberg
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Bon Secours Saint Francis Cancer Center
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Seneca, South Carolina, Forenede Stater, 29672
- Prisma Health - Upstate
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Spartanburg, South Carolina, Forenede Stater, 29303
- Spartanburg Regional Healthcare System
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Research Institute
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Tennessee Oncology Medical Park II
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Chattanooga, Tennessee, Forenede Stater, 37404
- Tennessee Oncology Memorial Plaza
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Cleveland, Tennessee, Forenede Stater, 37311
- Tennessee Oncology Cleveland Clinic
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Crossville, Tennessee, Forenede Stater, 38555
- Tennessee Oncology CMC
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Dickson, Tennessee, Forenede Stater, 37055
- Tennessee Oncology Dickson
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Franklin, Tennessee, Forenede Stater, 37067
- Tennessee Oncology Franklin
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Gallatin, Tennessee, Forenede Stater, 37066
- Tennessee Oncology Gallatin
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Hermitage, Tennessee, Forenede Stater, 37076
- Tennessee Oncology Summit
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Lebanon, Tennessee, Forenede Stater, 37090
- Tennessee Oncology Lebanon
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Murfreesboro, Tennessee, Forenede Stater, 37129
- Tennessee Oncology Murfreesboro
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology Nashville
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology Midtown
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology SCCBC
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Nashville, Tennessee, Forenede Stater, 37205
- Tennessee Oncology St. Thomas West
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Nashville, Tennessee, Forenede Stater, 37207
- Tennessee Oncology Skyline
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Nashville, Tennessee, Forenede Stater, 37211
- Tennessee Oncology Southern Hills
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Shelbyville, Tennessee, Forenede Stater, 37160
- Tennessee Oncology Shelbyville
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Smyrna, Tennessee, Forenede Stater, 37167
- Tennessee Oncology Stonecrest
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Texas
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Amarillo, Texas, Forenede Stater, 79106
- Texas Oncology - West Texas
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Bedford, Texas, Forenede Stater, 76022
- Texas Oncology-Bedford
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Dallas, Texas, Forenede Stater, 75246
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, Forenede Stater, 75231
- Texas Oncology - Presbyterian Cancer Center Dallas
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Dallas, Texas, Forenede Stater, 75203
- TXO - Methodist Dallas Cancer Center
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Dallas, Texas, Forenede Stater, 75230
- Texas Oncology - Dallas Forest Ln
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Fort Worth, Texas, Forenede Stater, 76104
- Texas Oncology-Fort Worth
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Fort Worth, Texas, Forenede Stater, 76132
- Texas Oncology-Southwest Fort Worth
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Grapevine, Texas, Forenede Stater, 76051
- Texas Oncology - Grapevine
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Harlingen, Texas, Forenede Stater, 78550
- Texas Oncology Cancer Care and Research Center - Harlingen
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Longview, Texas, Forenede Stater, 75601
- Texas Oncology - Longview Cancer Center
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McAllen, Texas, Forenede Stater, 78503
- Texas Oncology - McAllen
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Mesquite, Texas, Forenede Stater, 75150
- Texas Oncology - Mesquite
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New Braunfels, Texas, Forenede Stater, 78130
- Texas Oncology-New Braunfels
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Plano, Texas, Forenede Stater, 75093
- Texas Oncology - Plano West
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Plano, Texas, Forenede Stater, 75075
- Texas Oncology - Plano East
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Rockwall, Texas, Forenede Stater, 75032
- Texas Oncology - Rockwall
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San Antonio, Texas, Forenede Stater, 78217
- Texas Oncology - San Antonio Northeast
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San Antonio, Texas, Forenede Stater, 78212
- Texas Oncology-San Antonio Downtown
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San Antonio, Texas, Forenede Stater, 78258
- Texas Oncology-San Antonio Stone Oak
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San Antonio, Texas, Forenede Stater, 78229
- Texas Oncology-San Antonio Medical Center
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Sherman, Texas, Forenede Stater, 75090
- Texas Oncology - Sherman
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The Woodlands, Texas, Forenede Stater, 77380
- Texas Oncology-The Woodlands
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Tyler, Texas, Forenede Stater, 75702
- Texas Oncology - Tyler
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Weslaco, Texas, Forenede Stater, 78503
- Texas Oncology - Weslaco
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Wichita Falls, Texas, Forenede Stater, 76310
- Texas Oncology - West Texas
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Virginia
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Alexandria, Virginia, Forenede Stater, 22304
- Virginia Cancer Specialists, Pc
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Arlington, Virginia, Forenede Stater, 22205
- Virginia Cancer Specialists, Pc
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Fairfax, Virginia, Forenede Stater, 22031
- Virginia Cancer Specialists, Pc
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Gainesville, Virginia, Forenede Stater, 20155
- Virginia Cancer Specialists, Pc
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Leesburg, Virginia, Forenede Stater, 20176
- Virginia Cancer Specialists, Pc
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Woodbridge, Virginia, Forenede Stater, 22191
- Virginia Cancer Specialists, Pc
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Benaroya Research Institute at Virginia Mason
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Vancouver, Washington, Forenede Stater, 98684
- Northwest Cancer Specialists, P.C. dba Compass Oncology
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Yakima, Washington, Forenede Stater, 98902
- Yakima Valley Memorial Hospital/North Star Lodge
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier for ikke-kræftarmsdeltagere:
- Alder 20 år eller ældre
- Kan give et skriftligt informeret samtykke
Eksklusionskriterier for ikke-kræftarmsdeltagere:
- Kendt nuværende eller tidligere diagnose af cancer undtagen ikke-melanom hudkræft
- Oral eller IV kortikosteroidbrug i de sidste 14 dage før blodudtagning
- Graviditet (ved selvrapportering)
- Aktuel febersygdom
- Akut forværring eller opblussen af en inflammatorisk tilstand, der kræver optrapning i medicinsk behandling inden for 14 dage før blodudtagning.
- Modtager af organtransplantation eller tidligere ikke-autolog (allogen) knoglemarvs- eller stamcelletransplantation
- Dårlig helbredstilstand eller uegnet til at tolerere blodudtagning
Inklusionskriterier for kræftarmsdeltagere:
- Alder 20 år eller ældre
- Kan give et skriftligt informeret samtykke
Har en af følgende:
A. Bekræftet kræftdiagnose (enhver fase I-IV såvel som carcinoma in situ (CIS) inden for 90 dage før eller op til 42 dage efter undersøgelsens blodudtagning, baseret på vurdering af en patologisk prøve
ELLER
B. En høj mistanke om en kræftdiagnose ved klinisk og/eller radiologisk vurdering med planlagt biopsi eller kirurgisk resektion for at etablere en endelig diagnose inden for 6 uger (42 dage) efter undersøgelsens blodudtagning
Eksklusionskriterier for kræftarmsdeltagere:
- Kendt tidligere diagnose af kræft undtagen hudkræft uden melanom
- Modtager i øjeblikket eller nogensinde har modtaget nogen af følgende terapier til behandling af deres nuværende kræft: kirurgisk behandling af kræften ud over det, der kræves for at etablere kræftdiagnosen; lokal, regional eller systemisk kemoterapi, herunder kemoembolisering; målrettet terapi, immunterapi inklusive cancervacciner; hormonbehandling; eller strålebehandling
- Graviditet (ved selvrapportering)
- Aktuel febersygdom
- Akut forværring eller opblussen af en inflammatorisk tilstand, der kræver optrapning i medicinsk behandling inden for 14 dage før blodudtagning.
- Modtager af organtransplantation eller tidligere ikke-autolog (allogen) knoglemarvs- eller stamcelletransplantation
- Dårlig helbredstilstand eller uegnet til at tolerere blodudtagning
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Kræftarm
Deltagere med ny diagnose af cancer (flere tumortyper), hvorfra en blodprøve og samtidig FFPE-tumorvæv vil blive indsamlet.
|
Ikke-kræftarm
Deltagere uden kendt diagnose eller tidligere kræfthistorie, hvorfra der vil blive udtaget en blodprøve.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
At indsamle og studere klinisk annoterede bioprøver, specifikt perifert blod og moderne tumorvæv, når det er tilgængeligt, for at karakterisere cfNA-profiler fra dyb sekventering og for at estimere populationsheterogeniteten i to arme af undersøgelsen.
Tidsramme: 30 måneder
|
30 måneder
|
At udvikle og evaluere modeller til at skelne mellem kræft og ikke-kræft og oprindelsesvæv.
Tidsramme: 30 måneder
|
30 måneder
|
At evaluere konkordans af varianter identificeret i sekventering af tumorvæv og cfNA-sekventering resulterer i plasma fra det samme individ.
Tidsramme: 30 måneder
|
30 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
At udforske forholdet mellem genomiske resultater og kliniske resultater baseret på indsamling af longitudinelle oplysninger (mindst årligt i op til 5 år) fra lægejournaler for alle samtykkende deltagere.
Tidsramme: År 1, 2, 3, 4, 5
|
År 1, 2, 3, 4, 5
|
For at muliggøre vurdering af ydeevnen af en analytisk valideret klinisk laboratorieversion af NGS-assayet (under udvikling) til påvisning af cirkulerende tumor-DNA (ctDNA) i plasma.
Tidsramme: År 1, 2, 3, 4, 5
|
År 1, 2, 3, 4, 5
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Eric Fung, MD, PhD, GRAIL, LLC
Publikationer og nyttige links
Generelle publikationer
- Bredno J, Lipson J, Venn O, Aravanis AM, Jamshidi A. Clinical correlates of circulating cell-free DNA tumor fraction. PLoS One. 2021 Aug 25;16(8):e0256436. doi: 10.1371/journal.pone.0256436. eCollection 2021.
- Klein EA, Richards D, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J, Hunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C, Liu MC. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806. Epub 2021 Jun 24.
- Larson MH, Pan W, Kim HJ, Mauntz RE, Stuart SM, Pimentel M, Zhou Y, Knudsgaard P, Demas V, Aravanis AM, Jamshidi A. A comprehensive characterization of the cell-free transcriptome reveals tissue- and subtype-specific biomarkers for cancer detection. Nat Commun. 2021 Apr 21;12(1):2357. doi: 10.1038/s41467-021-22444-1. Erratum In: Nat Commun. 2022 May 4;13(1):2553.
- Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.
- Shao SH, Allen B, Clement J, Chung G, Gao J, Hubbell E, Liu MC, Swanton C, Tang WHW, Yimer H, Tummala M. Multi-cancer early detection test sensitivity for cancers with and without current population-level screening options. Tumori. 2023 Jun;109(3):335-341. doi: 10.1177/03008916221133136. Epub 2022 Oct 31.
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 (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- GRAIL-001
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 Neoplasmer
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Guangzhou First People's HospitalAfsluttet