Genetics Study of Tissue Collected From Patients With Acute Myeloid Leukemia
Molecular Genetic Studies of Acute Myeloid Leukemia (AML) With Normal Cytogenetics. A CALGB Leukemia Tissue Bank Project
RATIONALE: Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in the DNA of tissue samples that were collected from patients with acute myeloid leukemia.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- Validate, on the larger number of patients with karyotypically normal acute myeloid leukemia (AML) treated uniformly on CALGB-19808, preliminary results from CALGB-9621 showing that BAALC and ERG overexpression and microarray gene-expression signatures can stratify the patients prognostically.
- Establish whether microRNAs are differentially expressed in subsets of patients with AML and normal cytogenetics, and, if so, attempt to identify a signature that stratifies patients prognostically.
- Explore the relative contribution in predicting clinical outcome of patients with cytogenetically normal AML using genetic markers such as BAALC, ERG, and EVI1 overexpression, MLL partial tandem duplication, FLT3 internal tandem duplication, NPM1 and CEBPA mutations, and microarray gene expression microRNA signatures.
OUTLINE: This is a multicenter, pilot study.
Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays. Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Ohio
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Columbus, Ohio, Forenede Stater, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia
- Normal karyotype
Bone marrow and/or peripheral blood samples from patients treated on CALGB-19808 and registered on CALGB-9665 required
- No additional samples required
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Group 1
Peripheral blood and bone marrow samples are analyzed to assess gene expression using polymerase chain reaction (PCR) or reverse transcriptase-PCR assays and microarray assays.
Genes to be studied include BAALC, ERB, EVI1, MLL, FLT3, NPM1, and CEBPA.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures
Tidsramme: Baseline
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Baseline
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Differential microRNA expression
Tidsramme: Baseline
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Baseline
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Relative contribution of genetic markers in predicting clinical outcome
Tidsramme: Baseline
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Baseline
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Guido Marcucci, MD, Ohio State University Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- ubehandlet akut myeloid leukæmi hos voksne
- akut megakaryoblastisk leukæmi hos voksne (M7)
- voksen akut minimalt differentieret myeloid leukæmi (M0)
- akut monoblastisk leukæmi hos voksne (M5a)
- akut monocytisk leukæmi hos voksne (M5b)
- akut myeloblastisk leukæmi hos voksne med modning (M2)
- voksen akut myeloblastisk leukæmi uden modning (M1)
- akut myelomonocytisk leukæmi hos voksne (M4)
- akut basofil leukæmi hos voksne
- akut eosinofil leukæmi hos voksne
- voksen erythroleukæmi (M6a)
- ren erythroid leukæmi hos voksne (M6b)
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CALGB-20502
- U10CA180821 (U.S. NIH-bevilling/kontrakt)
- U10CA031946 (U.S. NIH-bevilling/kontrakt)
- CDR0000491133 (Registry Identifier: NCI Physician Data Query)
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