- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00003931
Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia
Assessment of the Partial Tandem Duplication of ALL1 (MLL) in Patients With Acute Myeloid Leukemia- A CALGB Leukemia Tissue Bank Project
RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute myeloid leukemia and determine the extent of disease.
PURPOSE: Diagnostic study to try to detect changes in the genes of patients who have acute myeloid leukemia.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine the frequency of partial tandem duplication of ALL1 (MLL) in patients with acute myeloid leukemia (AML).
- Determine the predictive value of partial tandem duplication of ALL1 to identify a subset of AML patients who have a short duration of complete remission.
OUTLINE: All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected.
Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Alabama
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Birmingham, Alabama, Forente stater, 35233-1996
- Veterans Affairs Medical Center - Birmingham
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California
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La Jolla, California, Forente stater, 92093-0658
- University of California San Diego Cancer Center
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San Francisco, California, Forente stater, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Forente stater, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, Forente stater, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forente stater, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, Forente stater, 20007
- Lombardi Cancer Center
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Florida
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Miami Beach, Florida, Forente stater, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Forente stater, 60637-1470
- University of Chicago Cancer Research Center
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Iowa
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Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
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Maine
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Togus, Maine, Forente stater, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, Forente stater, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber Cancer Institute
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Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Forente stater, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Forente stater, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, Forente stater, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Forente stater, 68198-3330
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center
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New York
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Forente stater, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, Forente stater, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Forente stater, 11030
- Schneider Children's Hospital at North Shore
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New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forente stater, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, Forente stater, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, Forente stater, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Forente stater, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, Forente stater, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, Forente stater, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, Forente stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, Forente stater, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, Forente stater, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, Forente stater, 38103
- University of Tennessee, Memphis Cancer Center
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Memphis, Tennessee, Forente stater, 38104
- Veterans Affairs Medical Center - Memphis
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Vermont
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Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center
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White River Junction, Vermont, Forente stater, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, Forente stater, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, Forente stater, 23249
- Veterans Affairs Medical Center - Richmond
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
DISEASE CHARACTERISTICS:
- Prior registration on protocol CALGB-9665
- Diagnosed with acute myeloid leukemia (AML)
- Treated on a CALGB AML treatment protocol
- Diagnostic bone marrow or blood specimen available
PATIENT CHARACTERISTICS:
Age:
- 15 and over
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
blood or bone marrow samples
All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected CALGB-9769. Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
frequency of partial tandem duplication of ALL1 (MLL)
Tidsramme: Up to 10 years
|
Up to 10 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
predictive value of partial tandem duplication of ALL1
Tidsramme: Up to 10 years
|
Up to 10 years
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Michael A. Caligiuri, MD, Ohio State University Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CALGB-9769
- U10CA031946 (U.S. NIH-stipend/kontrakt)
- CLB-9769
- CDR0000067123 (Registeridentifikator: NCI Physician Data Query)
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. .
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