- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Arizona
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Scottsdale, Arizona, États-Unis, 85259-5499
- Mayo Clinic Scottsdale
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Connecticut
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Hartford, Connecticut, États-Unis, 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, États-Unis, 32224
- Mayo Clinic - Jacksonville
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Idaho
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Boise, Idaho, États-Unis, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, États-Unis, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, États-Unis, 61701
- St. Joseph Medical Center
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Canton, Illinois, États-Unis, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, États-Unis, 61520
- Graham Hospital
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Carthage, Illinois, États-Unis, 62321
- Memorial Hospital
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Carthage, Illinois, États-Unis, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, États-Unis, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, États-Unis, 61530
- Eureka Community Hospital
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Galesburg, Illinois, États-Unis, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, États-Unis, 61401
- Galesburg Clinic, PC
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Havana, Illinois, États-Unis, 62644
- Mason District Hospital
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Havana, Illinois, États-Unis, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, États-Unis, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, États-Unis, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, États-Unis, 61455
- Mcdonough District Hospital
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Moline, Illinois, États-Unis, 61265
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Moline, Illinois, États-Unis, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, États-Unis, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, États-Unis, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, États-Unis, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, États-Unis, 61761
- Community Cancer Center
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Normal, Illinois, États-Unis, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, États-Unis, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, États-Unis, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, États-Unis, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, États-Unis, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, États-Unis, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, États-Unis, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, États-Unis, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, États-Unis, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, États-Unis, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, États-Unis, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, États-Unis, 61356
- Perry Memorial Hospital
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Princeton, Illinois, États-Unis, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, États-Unis, 61362
- Illinois CancerCare - Spring Valley
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Iowa
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Bettendorf, Iowa, États-Unis, 52722
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Cedar Rapids, Iowa, États-Unis, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, États-Unis, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Sioux City, Iowa, États-Unis, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, États-Unis, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, États-Unis, 51104
- St. Luke's Regional Medical Center
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Michigan
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Adrian, Michigan, États-Unis, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, États-Unis, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, États-Unis, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, États-Unis, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, États-Unis, 48503
- Hurley Medical Center
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Flint, Michigan, États-Unis, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, États-Unis, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, États-Unis, 49201
- Foote Memorial Hospital
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Lansing, Michigan, États-Unis, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, États-Unis, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, États-Unis, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, États-Unis, 48162
- Mercy Memorial Hospital - Monroe
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Pontiac, Michigan, États-Unis, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, États-Unis, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, États-Unis, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Warren, Michigan, États-Unis, 48093
- St. John Macomb Hospital
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Minnesota
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Bemidji, Minnesota, États-Unis, 56601
- MeritCare Bemidji
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Duluth, Minnesota, États-Unis, 55805
- CCOP - Duluth
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Duluth, Minnesota, États-Unis, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, États-Unis, 55805
- Miller - Dwan Medical Center
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, États-Unis, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, États-Unis, 56303
- Coborn Cancer Center
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New York
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New York, New York, États-Unis, 10029
- Mount Sinai Medical Center
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North Dakota
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Bismarck, North Dakota, États-Unis, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, États-Unis, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, États-Unis, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, États-Unis, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, États-Unis, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, États-Unis, 58102
- MeritCare Broadway
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Fargo, North Dakota, États-Unis, 58122
- Roger Maris Cancer Center at MeritCare Hospital
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Ohio
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Bowling Green, Ohio, États-Unis, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, États-Unis, 45601
- Adena Regional Medical Center
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Columbus, Ohio, États-Unis, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, États-Unis, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, États-Unis, 43215
- CCOP - Columbus
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Columbus, Ohio, États-Unis, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, États-Unis, 43228
- Doctors Hospital at Ohio Health
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Delaware, Ohio, États-Unis, 43015
- Grady Memorial Hospital
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Elyria, Ohio, États-Unis, 44035
- Community Cancer Center
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Elyria, Ohio, États-Unis, 44035
- Hematology Oncology Center
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Lancaster, Ohio, États-Unis, 43130
- Fairfield Medical Center
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Lima, Ohio, États-Unis, 45804
- Lima Memorial Hospital
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Marietta, Ohio, États-Unis, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, États-Unis, 43537-1839
- Northwest Ohio Oncology Center
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Mount Vernon, Ohio, États-Unis, 43050
- Knox Community Hospital
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Newark, Ohio, États-Unis, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, États-Unis, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, États-Unis, 43616
- Toledo Clinic - Oregon
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Portsmouth, Ohio, États-Unis, 45662
- Southern Ohio Medical Center Cancer Center
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Sandusky, Ohio, États-Unis, 44870
- North Coast Cancer Care, Incorporated
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Springfield, Ohio, États-Unis, 45505
- Community Hospital of Springfield and Clark County
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Sylvania, Ohio, États-Unis, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, États-Unis, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, États-Unis, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, États-Unis, 43606
- Toledo Hospital
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Toledo, Ohio, États-Unis, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, États-Unis, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, États-Unis, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, États-Unis, 43623
- St. Anne Mercy Hospital
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Wauseon, Ohio, États-Unis, 43567
- Fulton County Health Center
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Westerville, Ohio, États-Unis, 43081
- Mount Carmel St. Ann's Cancer Center
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Zanesville, Ohio, États-Unis, 43701
- Genesis - Good Samaritan Hospital
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South Dakota
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Rapid City, South Dakota, États-Unis, 57701
- Rapid City Regional Hospital
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Virginia
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Fredericksburg, Virginia, États-Unis, 22401
- Fredericksburg Oncology, Incorporated
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
- 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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
time to progression
Délai: baseline
|
baseline
|
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survival
Délai: baseline
|
baseline
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NCCTG-94-72-52
- NCCTG-947252
- CDR0000406625 (Identificateur de registre: PDQ (Physician Data Query))
- NCI-2009-00688 (Identificateur de registre: CTRP (Clinical Trials Reporting System))
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