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NCT01146223 Clinical Trial

Biomarkers in Bone Marrow Samples From Patients With Acute Promyelocytic Leukemia

Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Clinical Trial

Official title:
Observational - WT-1's Role in Leukemogenesis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01146223
Other study ID # AAML10B7
Secondary ID NCI-2012-02717CD
Status Completed
Phase N/A
First received June 16, 2010
Last updated May 6, 2015
Start date September 2009
Est. completion date June 2011

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

Clinical Trial Summary

This research study is studying biomarkers in patients with acute promyelocytic leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and about biomarkers related to cancer.

Description:

OBSERVATIONAL STUDY MODEL: Case-only TIME PERSPECTIVE: Retrospective BIOSPECIMEN RETENTION: Samples With DNA BIOSCPECIMEN DESCRIPTION: Bone marrow STUDY POPULATION DESCRIPTION: Primary Care Clinic SAMPLING METHOD: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To measure WT1 and VEGF-1 expression in patients with acute promyelocytic leukemia.

OUTLINE: This is a multicenter study.

Patient mRNA samples from diagnosis are analyzed via quantitative PCR to measure WT1 and VEGF-1 expression.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of acute promyelocytic leukemia [t(15;17) translocation]

- Not specified

- Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations
Country Name City State
United States Children's Oncology Group Monrovia California

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

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary WT1 and VEGF-1 expression Baseline No
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