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OpenTrials
Completed

NCT Number: NCT00897182

Identifying Cancer Genes in in Blood and Bone Marrow Samples From Patients With Acute Myeloid Leukemia

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Observational

Primary location

Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

microarray analysis

Genetic

polymerase chain reaction

Genetic

Primary outcomes

  1. Correlation of increased or decreased expression of same transcripts with disease outcome

    Time frame: baseline

  2. Minimum number of genes that can be used for precise diagnosis of each of the three subtypes of acute myeloid leukemia

    Time frame: baseline

  3. Identification of individual genes that are differentially expressed between the subtypes of AMLs

    Time frame: baseline

  4. Correlation of the patterns of expression of the translocation-specific transcripts with age, sex, race, response to treatment, survival, and with other known mutations

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Identification of Target Genes for Diagnosis and Prognosis of AML Using a Custom-Design Microarray

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
May 12, 2009
Registry last updated
Jul 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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