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NCT01553162 Clinical Trial

Studying Dexamethasone and Prednisone Sensitivity in Samples From Younger Patients With High-Risk B-Cell Precursor Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:
B-precursor Acute Lymphoblastic Leukemia (ALL): Studying the Mechanisms Behind Dexamethasone and Prednisone Sensitivity in High-Risk Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01553162
Other study ID # AALL12B4
Secondary ID COG-AALL12B4CDR0
Status Completed
Phase N/A
First received March 10, 2012
Last updated May 17, 2016
Start date April 2012

Study information
Verified date May 2016
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, tissue, or bone marrow 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 trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.

Description:

OBJECTIVES:

- Identify differences in the effect of dexamethasone (Dex) and prednisone (Pred) on glucocorticoid receptor (GR) occupancy and gene expression in high-risk (HR) B-cell precursor (BCP)-acute lymphoblastic leukemia (ALL) samples from patients aged 1-9.

- Identify differences in gene expression and GR occupancy of response elements in HR BCP-ALL patients > 10 years old in response to both Dex and Pred.

OUTLINE: Archived samples are analyzed for gene expression analysis and genomic location of glucocorticoid receptor by ChIP sequencing (ChiPseq) and RNA sequencing. Data of gene expression and ChiPseq data sets are compared by luciferase reporter assay.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 21 Years
Eligibility DISEASE CHARACTERISTICS:

- Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia

- Samples from patients treated and not treated with Dex and Pred

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• RNA analysis

• gene expression analysis

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 Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old No
Primary Genes that are required for efficient apoptosis No
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