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OpenTrials
Completed

NCT Number: NCT01553162

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA analysis

Genetic

RNA analysis

Genetic

gene expression analysis

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old

  2. Genes that are required for efficient apoptosis

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
First posted
Mar 14, 2012
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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