- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5499
- Mayo Clinic Scottsdale
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Connecticut
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Hartford, Connecticut, Estados Unidos, 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, Estados Unidos, 32224
- Mayo Clinic - Jacksonville
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Idaho
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Boise, Idaho, Estados Unidos, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, Estados Unidos, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, Estados Unidos, 61701
- St. Joseph Medical Center
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Canton, Illinois, Estados Unidos, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Estados Unidos, 61520
- Graham Hospital
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Carthage, Illinois, Estados Unidos, 62321
- Memorial Hospital
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Carthage, Illinois, Estados Unidos, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Estados Unidos, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Estados Unidos, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Estados Unidos, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Estados Unidos, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Estados Unidos, 62644
- Mason District Hospital
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Havana, Illinois, Estados Unidos, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Estados Unidos, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Estados Unidos, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Estados Unidos, 61455
- Mcdonough District Hospital
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Moline, Illinois, Estados Unidos, 61265
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Moline, Illinois, Estados Unidos, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Estados Unidos, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Estados Unidos, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Estados Unidos, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Estados Unidos, 61761
- Community Cancer Center
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Normal, Illinois, Estados Unidos, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Estados Unidos, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Estados Unidos, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Estados Unidos, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Estados Unidos, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Estados Unidos, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Estados Unidos, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Estados Unidos, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Estados Unidos, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Estados Unidos, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Estados Unidos, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Estados Unidos, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Estados Unidos, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Estados Unidos, 61362
- Illinois CancerCare - Spring Valley
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Iowa
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Bettendorf, Iowa, Estados Unidos, 52722
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Cedar Rapids, Iowa, Estados Unidos, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Estados Unidos, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Sioux City, Iowa, Estados Unidos, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Estados Unidos, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, Estados Unidos, 51104
- St. Luke's Regional Medical Center
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Michigan
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Adrian, Michigan, Estados Unidos, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Estados Unidos, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, Estados Unidos, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Flint, Michigan, Estados Unidos, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Estados Unidos, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, Estados Unidos, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Estados Unidos, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Estados Unidos, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Estados Unidos, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Estados Unidos, 48162
- Mercy Memorial Hospital - Monroe
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Pontiac, Michigan, Estados Unidos, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Estados Unidos, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Estados Unidos, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Warren, Michigan, Estados Unidos, 48093
- St. John Macomb Hospital
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Minnesota
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Bemidji, Minnesota, Estados Unidos, 56601
- MeritCare Bemidji
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Duluth, Minnesota, Estados Unidos, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Estados Unidos, 55805
- Miller - Dwan Medical Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Estados Unidos, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Estados Unidos, 56303
- Coborn Cancer Center
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Estados Unidos, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Estados Unidos, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Estados Unidos, 58102
- MeritCare Broadway
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Fargo, North Dakota, Estados Unidos, 58122
- Roger Maris Cancer Center at MeritCare Hospital
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Ohio
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Bowling Green, Ohio, Estados Unidos, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Estados Unidos, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Estados Unidos, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Estados Unidos, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Estados Unidos, 43215
- CCOP - Columbus
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Columbus, Ohio, Estados Unidos, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, Estados Unidos, 43228
- Doctors Hospital at Ohio Health
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Delaware, Ohio, Estados Unidos, 43015
- Grady Memorial Hospital
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Elyria, Ohio, Estados Unidos, 44035
- Community Cancer Center
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Elyria, Ohio, Estados Unidos, 44035
- Hematology Oncology Center
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Lancaster, Ohio, Estados Unidos, 43130
- Fairfield Medical Center
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Lima, Ohio, Estados Unidos, 45804
- Lima Memorial Hospital
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Marietta, Ohio, Estados Unidos, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, Estados Unidos, 43537-1839
- Northwest Ohio Oncology Center
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Mount Vernon, Ohio, Estados Unidos, 43050
- Knox Community Hospital
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Newark, Ohio, Estados Unidos, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, Estados Unidos, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Estados Unidos, 43616
- Toledo Clinic - Oregon
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Portsmouth, Ohio, Estados Unidos, 45662
- Southern Ohio Medical Center Cancer Center
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Sandusky, Ohio, Estados Unidos, 44870
- North Coast Cancer Care, Incorporated
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Springfield, Ohio, Estados Unidos, 45505
- Community Hospital of Springfield and Clark County
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Sylvania, Ohio, Estados Unidos, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Estados Unidos, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Estados Unidos, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Estados Unidos, 43606
- Toledo Hospital
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Toledo, Ohio, Estados Unidos, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Estados Unidos, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Estados Unidos, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Estados Unidos, 43623
- St. Anne Mercy Hospital
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Wauseon, Ohio, Estados Unidos, 43567
- Fulton County Health Center
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Westerville, Ohio, Estados Unidos, 43081
- Mount Carmel St. Ann's Cancer Center
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Zanesville, Ohio, Estados Unidos, 43701
- Genesis - Good Samaritan Hospital
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57701
- Rapid City Regional Hospital
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Virginia
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Fredericksburg, Virginia, Estados Unidos, 22401
- Fredericksburg Oncology, Incorporated
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
- 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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
time to progression
Periodo de tiempo: baseline
|
baseline
|
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survival
Periodo de tiempo: baseline
|
baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NCCTG-94-72-52
- NCCTG-947252
- CDR0000406625 (Identificador de registro: PDQ (Physician Data Query))
- NCI-2009-00688 (Identificador de registro: CTRP (Clinical Trials Reporting System))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .