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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01553162
First Posted: March 14, 2012
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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.


Condition Intervention
Leukemia Genetic: DNA analysis Genetic: RNA analysis Genetic: gene expression analysis Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: B-precursor Acute Lymphoblastic Leukemia (ALL): Studying the Mechanisms Behind Dexamethasone and Prednisone Sensitivity in High-Risk Patients

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old
  • Genes that are required for efficient apoptosis

Estimated Enrollment: 20
Study Start Date: April 2012
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553162


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Miles A. Pufall, PhD University of Iowa
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01553162     History of Changes
Other Study ID Numbers: AALL12B4
COG-AALL12B4 ( Other Identifier: Children's Oncology Group )
CDR0000728515 ( Other Identifier: clinicaltrials.gov )
AALL12B4 ( Other Identifier: COG )
NCI-2012-00704 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: March 10, 2012
First Posted: March 14, 2012
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
B-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Prednisone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action