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

Recurrent Childhood Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Molecular Taxonomy of Pediatric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625143
• Other study ID #: AALL12B7
• Secondary ID: NCI-2012-01976CD
• Status: Completed
• Phase: N/A
• First received: June 17, 2012
• Last updated: May 17, 2016
• Start date: June 2012

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• B-cell Childhood Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Untreated Childhood Acute Lymphoblastic Leukemia

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Arcadia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cellular origins of relapse and the underlying epigenetic mechanisms associated with drug resistance		1 month	No
Primary	Genes associated with histone modification		1 month	No
Primary	Biological pathways involved in relapse		1 month	No