Clinical trial NCT00897182: Identifying Cancer Genes in in Blood and Bone Marrow Samples From Patients With Acute Myeloid Leukemia
Official title: Identification of Target Genes for Diagnosis and Prognosis of AML Using a Custom-Design Microarray
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia in remission
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(8;21)(q22;q22)
childhood acute myeloid leukemia in remission
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acute myeloid leukemia.

Brief summary: RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify genes related to cancer. It may also help doctors diagnose cancer and predict how patients will respond to treatment.

PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To identify and validate individual genes for diagnosis of three major translocations in acute myeloid leukemia.
* To correlate transcript expression data in the various translocations with age, sex, race, response to treatment, and survival and with other known mutations.

OUTLINE: Blood and/or bone marrow samples previously procured from patients on CALGB-9665 are obtained from the CALGB Leukemia Tissue Bank from patients enrolled on CALGB AML treatment studies. Mononuclear cells are isolated from samples and mRNA is extracted. Gene expression profiles are analyzed via custom mRNA microarray and confirmed by quantitative real-time PCR.

Eligibility criteria: * Enrolled on CALGB acute myeloid leukemia (AML) treatment studies AND concurrently enrolled on Leukemia Tissue Bank Protocol CALGB-9665
* Short-term or long-term survivor
* Bone marrow and/or peripheral blood obtained at diagnosis
* Leukemia is one of the following cytogenetic subtypes:

  * t(8;21)
  * t(15;17)
  * inv(16)

Primary outcomes:
measure: Correlation of increased or decreased expression of same transcripts with disease outcome
timeFrame: baseline
measure: Minimum number of genes that can be used for precise diagnosis of each of the three subtypes of acute myeloid leukemia
timeFrame: baseline
measure: Identification of individual genes that are differentially expressed between the subtypes of AMLs
timeFrame: baseline
measure: Correlation of the patterns of expression of the translocation-specific transcripts with age, sex, race, response to treatment, survival, and with other known mutations
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital, Incorporated
state: North Carolina
Study officials:
affiliation: University of Chicago
name: Janet Rowley, MD
role: STUDY_CHAIR
References: