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

NCT ID: NCT01553162

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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DNA analysis

Intervention Type GENETIC

RNA analysis

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miles A. Pufall, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Other Identifiers

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COG-AALL12B4

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000728515

Identifier Type: OTHER

Identifier Source: secondary_id

AALL12B4

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00704

Identifier Type: REGISTRY

Identifier Source: secondary_id

AALL12B4

Identifier Type: -

Identifier Source: org_study_id

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