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

Completed

• Conditions: Recurrent Childhood Acute Lymphoblastic Leukemia; B-cell Childhood Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01625143
• Lead Sponsor: Children's Oncology Group

Brief 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.

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).

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-17
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-21
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	laboratory biomarker analysis	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).

Primary Outcome Measures

Name	Time	Method
Biological pathways involved in relapse	1 month
Genes associated with histone modification	1 month
Cellular origins of relapse and the underlying epigenetic mechanisms associated with drug resistance	1 month

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Arcadia, California, United States