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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00898092

Enrollment

735

Registered

2009-05-12

Start date

2006-05-31

Completion date

Unknown

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

adult acute minimally differentiated myeloid leukemia (M0), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloblastic leukemia with maturation (M2), adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute eosinophilic leukemia, adult acute basophilic leukemia, untreated adult acute myeloid leukemia

Brief summary

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.

Detailed description

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.

Interventions

GENETICmicroarray analysis

GENETICmolecular genetic technique

GENETICmutation analysis

GENETICpolymerase chain reaction

GENETICreverse transcriptase-polymerase chain reaction

OTHERdiagnostic laboratory biomarker analysis

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to 59 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Prognostic stratification of patients through BAALC and ERG overexpression and microarray gene-expression signatures	Baseline
Differential microRNA expression	Baseline
Relative contribution of genetic markers in predicting clinical outcome	Baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026