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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897182
• Other study ID #: CALGB-20801
• Secondary ID: CALGB-20801CDR00
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: July 1, 2016
• Start date: May 2008
• Est. completion date: March 2014

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

• 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)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• microarray analysis

• polymerase chain reaction

Locations

Country	Name	City	State
United States	Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of increased or decreased expression of same transcripts with disease outcome		baseline	No
Primary	Minimum number of genes that can be used for precise diagnosis of each of the three subtypes of acute myeloid leukemia		baseline	No
Primary	Identification of individual genes that are differentially expressed between the subtypes of AMLs		baseline	No
Primary	Correlation of the patterns of expression of the translocation-specific transcripts with age, sex, race, response to treatment, survival, and with other known mutations		baseline	No