Study of Tissue and Blood Samples From Patients With High-Grade Glioma
16. januar 2019 oppdatert av: Alliance for Clinical Trials in Oncology
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
631
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Scottsdale, Arizona, Forente stater, 85259-5499
- Mayo Clinic Scottsdale
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Connecticut
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Hartford, Connecticut, Forente stater, 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, Forente stater, 32224
- Mayo Clinic - Jacksonville
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Idaho
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Boise, Idaho, Forente stater, 83706
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
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Illinois
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Bloomington, Illinois, Forente stater, 61701
- Illinois CancerCare - Bloomington
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Bloomington, Illinois, Forente stater, 61701
- St. Joseph Medical Center
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Canton, Illinois, Forente stater, 61520
- Illinois CancerCare - Canton
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Canton, Illinois, Forente stater, 61520
- Graham Hospital
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Carthage, Illinois, Forente stater, 62321
- Memorial Hospital
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Carthage, Illinois, Forente stater, 62321
- Illinois CancerCare - Carthage
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Eureka, Illinois, Forente stater, 61530
- Illinois CancerCare - Eureka
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Eureka, Illinois, Forente stater, 61530
- Eureka Community Hospital
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Galesburg, Illinois, Forente stater, 61401
- Illinois CancerCare - Galesburg
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Galesburg, Illinois, Forente stater, 61401
- Galesburg Clinic, PC
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Havana, Illinois, Forente stater, 62644
- Mason District Hospital
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Havana, Illinois, Forente stater, 62644
- Illinois CancerCare - Havana
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Kewanee, Illinois, Forente stater, 61443
- Illinois CancerCare - Kewanee Clinic
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Macomb, Illinois, Forente stater, 61455
- Illinois CancerCare - Macomb
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Macomb, Illinois, Forente stater, 61455
- Mcdonough District Hospital
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Moline, Illinois, Forente stater, 61265
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Moline, Illinois, Forente stater, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Monmouth, Illinois, Forente stater, 61462
- Illinois CancerCare - Monmouth
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Monmouth, Illinois, Forente stater, 61462
- OSF Holy Family Medical Center
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Normal, Illinois, Forente stater, 61761
- Bromenn Regional Medical Center
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Normal, Illinois, Forente stater, 61761
- Community Cancer Center
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Normal, Illinois, Forente stater, 61761
- Illinois CancerCare - Community Cancer Center
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Ottawa, Illinois, Forente stater, 61350
- Community Hospital of Ottawa
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Ottawa, Illinois, Forente stater, 61350
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
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Pekin, Illinois, Forente stater, 61554
- Cancer Treatment Center at Pekin Hospital
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Pekin, Illinois, Forente stater, 61603
- Illinois CancerCare - Pekin
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Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Forente stater, 61637
- OSF St. Francis Medical Center
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Peoria, Illinois, Forente stater, 61615
- CCOP - Illinois Oncology Research Association
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Peoria, Illinois, Forente stater, 61615
- Oncology Hematology Associates of Central Illinois, PC - Peoria
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Peru, Illinois, Forente stater, 61354
- Illinois CancerCare - Peru
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Peru, Illinois, Forente stater, 61354
- Illinois Valley Community Hospital
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Princeton, Illinois, Forente stater, 61356
- Perry Memorial Hospital
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Princeton, Illinois, Forente stater, 61356
- Illinois CancerCare - Princeton
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Spring Valley, Illinois, Forente stater, 61362
- Illinois CancerCare - Spring Valley
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Iowa
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Bettendorf, Iowa, Forente stater, 52722
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Cedar Rapids, Iowa, Forente stater, 52403
- Cedar Rapids Oncology Associates
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Cedar Rapids, Iowa, Forente stater, 52403
- Mercy Regional Cancer Center at Mercy Medical Center
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Sioux City, Iowa, Forente stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Forente stater, 51102
- Mercy Medical Center - Sioux City
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Sioux City, Iowa, Forente stater, 51104
- St. Luke's Regional Medical Center
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Michigan
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Adrian, Michigan, Forente stater, 49221
- Hickman Cancer Center at Bixby Medical Center
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Ann Arbor, Michigan, Forente stater, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, Forente stater, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, Forente stater, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, Forente stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forente stater, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, Forente stater, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, Forente stater, 49201
- Foote Memorial Hospital
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Lansing, Michigan, Forente stater, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, Forente stater, 48154
- St. Mary Mercy Hospital
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Monroe, Michigan, Forente stater, 48162
- Community Cancer Center of Monroe
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Monroe, Michigan, Forente stater, 48162
- Mercy Memorial Hospital - Monroe
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Pontiac, Michigan, Forente stater, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, Forente stater, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Saginaw, Michigan, Forente stater, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Warren, Michigan, Forente stater, 48093
- St. John Macomb Hospital
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Minnesota
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Bemidji, Minnesota, Forente stater, 56601
- MeritCare Bemidji
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Duluth, Minnesota, Forente stater, 55805
- CCOP - Duluth
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Duluth, Minnesota, Forente stater, 55805-1983
- Duluth Clinic Cancer Center - Duluth
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Duluth, Minnesota, Forente stater, 55805
- Miller - Dwan Medical Center
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Forente stater, 56303
- CentraCare Clinic - River Campus
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Saint Cloud, Minnesota, Forente stater, 56303
- Coborn Cancer Center
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New York
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center
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North Dakota
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Bismarck, North Dakota, Forente stater, 58501
- Bismarck Cancer Center
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Bismarck, North Dakota, Forente stater, 58501
- Medcenter One Hospital Cancer Care Center
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Bismarck, North Dakota, Forente stater, 58501
- Mid Dakota Clinic, PC
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Bismarck, North Dakota, Forente stater, 58502
- St. Alexius Medical Center Cancer Center
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Fargo, North Dakota, Forente stater, 58122
- CCOP - MeritCare Hospital
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Fargo, North Dakota, Forente stater, 58102
- MeritCare Broadway
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Fargo, North Dakota, Forente stater, 58122
- Roger Maris Cancer Center at MeritCare Hospital
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Ohio
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Bowling Green, Ohio, Forente stater, 43402
- Wood County Oncology Center
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Chillicothe, Ohio, Forente stater, 45601
- Adena Regional Medical Center
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Columbus, Ohio, Forente stater, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, Forente stater, 43222
- Mount Carmel Health - West Hospital
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Columbus, Ohio, Forente stater, 43215
- CCOP - Columbus
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Columbus, Ohio, Forente stater, 43215
- Grant Medical Center Cancer Care
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Columbus, Ohio, Forente stater, 43228
- Doctors Hospital at Ohio Health
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Delaware, Ohio, Forente stater, 43015
- Grady Memorial Hospital
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Elyria, Ohio, Forente stater, 44035
- Community Cancer Center
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Elyria, Ohio, Forente stater, 44035
- Hematology Oncology Center
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Lancaster, Ohio, Forente stater, 43130
- Fairfield Medical Center
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Lima, Ohio, Forente stater, 45804
- Lima Memorial Hospital
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Marietta, Ohio, Forente stater, 45750
- Strecker Cancer Center at Marietta Memorial Hospital
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Maumee, Ohio, Forente stater, 43537-1839
- Northwest Ohio Oncology Center
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Mount Vernon, Ohio, Forente stater, 43050
- Knox Community Hospital
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Newark, Ohio, Forente stater, 43055
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
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Oregon, Ohio, Forente stater, 43616
- St. Charles Mercy Hospital
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Oregon, Ohio, Forente stater, 43616
- Toledo Clinic - Oregon
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Portsmouth, Ohio, Forente stater, 45662
- Southern Ohio Medical Center Cancer Center
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Sandusky, Ohio, Forente stater, 44870
- North Coast Cancer Care, Incorporated
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Springfield, Ohio, Forente stater, 45505
- Community Hospital of Springfield and Clark County
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Sylvania, Ohio, Forente stater, 43560
- Flower Hospital Cancer Center
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Tiffin, Ohio, Forente stater, 44883
- Mercy Hospital of Tiffin
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Toledo, Ohio, Forente stater, 43608
- St. Vincent Mercy Medical Center
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Toledo, Ohio, Forente stater, 43606
- Toledo Hospital
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Toledo, Ohio, Forente stater, 43614
- Medical University of Ohio Cancer Center
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Toledo, Ohio, Forente stater, 43617
- CCOP - Toledo Community Hospital
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Toledo, Ohio, Forente stater, 43623
- Toledo Clinic, Incorporated - Main Clinic
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Toledo, Ohio, Forente stater, 43623
- St. Anne Mercy Hospital
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Wauseon, Ohio, Forente stater, 43567
- Fulton County Health Center
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Westerville, Ohio, Forente stater, 43081
- Mount Carmel St. Ann's Cancer Center
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Zanesville, Ohio, Forente stater, 43701
- Genesis - Good Samaritan Hospital
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South Dakota
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Rapid City, South Dakota, Forente stater, 57701
- Rapid City Regional Hospital
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Virginia
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Fredericksburg, Virginia, Forente stater, 22401
- Fredericksburg Oncology, Incorporated
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients with newly diagnosed high-grade gliomas participating in NCCTG/Alliance or Mayo protocols.
Beskrivelse
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
time to progression
Tidsramme: baseline
|
baseline
|
|
survival
Tidsramme: baseline
|
baseline
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 1995
Primær fullføring (Faktiske)
1. desember 2014
Studiet fullført (Faktiske)
15. januar 2019
Datoer for studieregistrering
Først innsendt
29. oktober 2009
Først innsendt som oppfylte QC-kriteriene
29. oktober 2009
Først lagt ut (Anslag)
30. oktober 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. januar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. januar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCCTG-94-72-52
- NCCTG-947252
- CDR0000406625 (Registeridentifikator: PDQ (Physician Data Query))
- NCI-2009-00688 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
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. .