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Studying Genes in Samples From Younger Patients With Relapsed Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625143
First Posted: June 21, 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
This laboratory study is looking into genes in samples from younger patients with relapsed acute lymphoblastic leukemia. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

Condition Intervention
B-cell Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Untreated Childhood Acute Lymphoblastic Leukemia Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Molecular Taxonomy of Pediatric Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Cellular origins of relapse and the underlying epigenetic mechanisms associated with drug resistance [ Time Frame: 1 month ]
  • Genes associated with histone modification [ Time Frame: 1 month ]
  • Biological pathways involved in relapse [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
Archived bone marrow samples

Estimated Enrollment: 40
Study Start Date: June 2012
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
Archived bone marrow samples, collected at the time of diagnosis and relapse, are analyzed for gene expression and histone modifications by microarray, chromatin immunoprecipitation (ChIP) sequencing, and quantitative real-time polymerase chain reaction (qRT-PCR).
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. To identify global changes in the epigenome and various underlying histone modifications that characterize relapsed acute lymphoblastic leukemia (ALL).

II. To identify specific transcription factor-binding sites associated with histone alterations.

III. To correlate gene expression changes of differentially regulated genes at relapse with underlying chromatin modifications.

OUTLINE:

Archived bone marrow samples, collected at the time of diagnosis and relapse, are analyzed for gene expression and histone modifications by microarray, chromatin immunoprecipitation (ChIP) sequencing, and quantitative real-time polymerase chain reaction (qRT-PCR).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of B-cell acute lymphoblastic leukemia
Criteria

Inclusion Criteria:

  • Diagnosis of B-cell acute lymphoblastic leukemia

    • Paired diagnosis-relapse primary patient samples obtained from the Children's Oncology Group (COG) cell bank
  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): NCT01625143


Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: William Carroll, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01625143     History of Changes
Other Study ID Numbers: AALL12B7
NCI-2012-01976 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000735342 ( Other Identifier: Clinical Trials.gov )
COG-AALL12B7 ( Other Identifier: Children's Oncology Group )
First Submitted: June 17, 2012
First Posted: June 21, 2012
Last Update Posted: May 18, 2016
Last Verified: May 2016

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