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NCT01138319 Clinical Trial

Biomarkers in Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:
Mitochondrial Mutations and AML

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01138319
Other study ID # AAML10B6
Secondary ID COG-AAML10B6CDR0
Status Completed
Phase N/A
First received June 4, 2010
Last updated May 5, 2015
Start date February 2009

Study information
Verified date May 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in patients with acute myeloid leukemia.

Description:

OBJECTIVES:

- To determine whether clonally expanded somatic mitochondrial DNA mutations are associated with acute myeloid leukemia.

OUTLINE: Genomic DNA from blood samples obtained at diagnosis, remission, and relapse are analyzed for mitochondrial DNA mutations via PCR.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia

- Available blood samples from diagnosis, remission, and relapse

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• mutation analysis

• polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Association between clonally expanded somatic mitochondrial DNA mutations and acute myeloid leukemia No
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