- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01004887
Study of Tissue and Blood Samples From Patients With High-Grade Glioma
Diagnostic And Prognostic Markers In High-Grade Glioma
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at tissue and blood samples from patients with high-grade glioma.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
- To evaluate the diagnostic and prognostic relevance of various molecular, cytogenetic, and other tumor markers in high-grade glioma in paraffin-embedded tissue collected from patients enrolled in the Mayo Clinic or North Central Cancer Treatment Group (NCCTG) high-grade glioma trials conducted since 1979.
- To evaluate alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y using PCR analysis of microsatellite repeats and FISH.
- To determine DNA ploidy by flow cytometric analysis.
- To examine various markers of cellular proliferation and cellular function including flow cytometric determination of %S-phase, %G2M, and immunohistochemical evaluation of PCNA, Ki-67, and p53.
- To evaluate additional markers identified by the Glioma Markers Network.
- To compare the incidence of markers in the major histologic subtypes (anaplastic astrocytoma [AA], anaplastic oligoastrocytoma [AOA], glioblastoma multiforme [GBM]) and to assess their correlation in the total group, as well as within each of these subtypes.
- To compare the ploidy determinations by FISH and flow cytometry.
OUTLINE: Paraffin-embedded tissue and peripheral blood samples, previously or currently collected from clinical trials participants at the time she/he enrolled in the trial, are evaluated for as many markers as possible, changes in cytogenic and molecular genetic tumor markers, frequency distributions of all tumor markers and histological and clinical variables by polymerase chain reaction, IHC, flow cytometry, and FISH analysis.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85259-5499
- Mayo Clinic Scottsdale
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Connecticut
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Hartford, Connecticut, Stati Uniti, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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Florida
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic - Jacksonville
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Idaho
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Boise, Idaho, Stati Uniti, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, Stati Uniti, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, Stati Uniti, 61701
- St. Joseph Medical Center
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Canton, Illinois, Stati Uniti, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Stati Uniti, 61520
- Graham Hospital
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Carthage, Illinois, Stati Uniti, 62321
- Memorial Hospital
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Carthage, Illinois, Stati Uniti, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Stati Uniti, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Stati Uniti, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Stati Uniti, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Stati Uniti, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Stati Uniti, 62644
- Mason District Hospital
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Havana, Illinois, Stati Uniti, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Stati Uniti, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Stati Uniti, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Stati Uniti, 61455
- Mcdonough District Hospital
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Moline, Illinois, Stati Uniti, 61265
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Moline, Illinois, Stati Uniti, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Stati Uniti, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Stati Uniti, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Stati Uniti, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Stati Uniti, 61761
- Community Cancer Center
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Normal, Illinois, Stati Uniti, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Stati Uniti, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Stati Uniti, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Stati Uniti, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Stati Uniti, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Stati Uniti, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stati Uniti, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Stati Uniti, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Stati Uniti, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Stati Uniti, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Stati Uniti, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Stati Uniti, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Stati Uniti, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Stati Uniti, 61362
- Illinois CancerCare - Spring Valley
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Iowa
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Bettendorf, Iowa, Stati Uniti, 52722
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Stati Uniti, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Sioux City, Iowa, Stati Uniti, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Stati Uniti, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, Stati Uniti, 51104
- St. Luke's Regional Medical Center
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Michigan
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Adrian, Michigan, Stati Uniti, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Stati Uniti, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Stati Uniti, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, Stati Uniti, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, Stati Uniti, 48503
- Hurley Medical Center
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Flint, Michigan, Stati Uniti, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Stati Uniti, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, Stati Uniti, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Stati Uniti, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Stati Uniti, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Stati Uniti, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Stati Uniti, 48162
- Mercy Memorial Hospital - Monroe
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Pontiac, Michigan, Stati Uniti, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Stati Uniti, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Stati Uniti, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Warren, Michigan, Stati Uniti, 48093
- St. John Macomb Hospital
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Minnesota
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Bemidji, Minnesota, Stati Uniti, 56601
- MeritCare Bemidji
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Duluth, Minnesota, Stati Uniti, 55805
- CCOP - Duluth
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Duluth, Minnesota, Stati Uniti, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Stati Uniti, 55805
- Miller - Dwan Medical Center
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Stati Uniti, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Stati Uniti, 56303
- Coborn Cancer Center
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New York
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New York, New York, Stati Uniti, 10029
- Mount Sinai Medical Center
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North Dakota
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Bismarck, North Dakota, Stati Uniti, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Stati Uniti, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Stati Uniti, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Stati Uniti, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Stati Uniti, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Stati Uniti, 58102
- MeritCare Broadway
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Fargo, North Dakota, Stati Uniti, 58122
- Roger Maris Cancer Center at MeritCare Hospital
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Ohio
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Bowling Green, Ohio, Stati Uniti, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Stati Uniti, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Stati Uniti, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Stati Uniti, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Stati Uniti, 43215
- CCOP - Columbus
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Columbus, Ohio, Stati Uniti, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, Stati Uniti, 43228
- Doctors Hospital at Ohio Health
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Delaware, Ohio, Stati Uniti, 43015
- Grady Memorial Hospital
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Elyria, Ohio, Stati Uniti, 44035
- Community Cancer Center
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Elyria, Ohio, Stati Uniti, 44035
- Hematology Oncology Center
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Lancaster, Ohio, Stati Uniti, 43130
- Fairfield Medical Center
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Lima, Ohio, Stati Uniti, 45804
- Lima Memorial Hospital
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Marietta, Ohio, Stati Uniti, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, Stati Uniti, 43537-1839
- Northwest Ohio Oncology Center
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Mount Vernon, Ohio, Stati Uniti, 43050
- Knox Community Hospital
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Newark, Ohio, Stati Uniti, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, Stati Uniti, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Stati Uniti, 43616
- Toledo Clinic - Oregon
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Portsmouth, Ohio, Stati Uniti, 45662
- Southern Ohio Medical Center Cancer Center
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Sandusky, Ohio, Stati Uniti, 44870
- North Coast Cancer Care, Incorporated
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Springfield, Ohio, Stati Uniti, 45505
- Community Hospital of Springfield and Clark County
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Sylvania, Ohio, Stati Uniti, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Stati Uniti, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Stati Uniti, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Stati Uniti, 43606
- Toledo Hospital
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Toledo, Ohio, Stati Uniti, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Stati Uniti, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Stati Uniti, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Stati Uniti, 43623
- St. Anne Mercy Hospital
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Wauseon, Ohio, Stati Uniti, 43567
- Fulton County Health Center
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Westerville, Ohio, Stati Uniti, 43081
- Mount Carmel St. Ann's Cancer Center
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Zanesville, Ohio, Stati Uniti, 43701
- Genesis - Good Samaritan Hospital
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South Dakota
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Rapid City, South Dakota, Stati Uniti, 57701
- Rapid City Regional Hospital
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Virginia
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Fredericksburg, Virginia, Stati Uniti, 22401
- Fredericksburg Oncology, Incorporated
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
- Patients with newly diagnosed high-grade gliomas
- Patients participating in NCCTG/Alliance or Mayo protocols
- Willing to provide mandatory blood and tissue samples for research purposes; note: 15 unstained slides may be submitted in place of a tissue block
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Single group
Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols.
Previously collected blood and tissue samples are analyzed via PCR, IHC, flow cytometry, and FISH.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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time to progression
Lasso di tempo: baseline
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baseline
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survival
Lasso di tempo: baseline
|
baseline
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Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NCCTG-94-72-52
- NCCTG-947252
- CDR0000406625 (Identificatore di registro: PDQ (Physician Data Query))
- NCI-2009-00688 (Identificatore di registro: CTRP (Clinical Trials Reporting System))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .