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

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01625143
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 40
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
B-cell Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia	Other: laboratory biomarker analysis

Detailed Description

OBJECTIVES:

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

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

3. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Molecular Taxonomy of Pediatric Cancer
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Cellular origins of relapse and the underlying epigenetic mechanisms associated with drug resistance [1 month]

2. Genes associated with histone modification [1 month]

3. Biological pathways involved in relapse [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01625143
• Other Study ID Numbers: AALL12B7; NCI-2012-01976; CDR0000735342; COG-AALL12B7
• First Posted: Jun 21, 2012
• Last Update Posted: May 18, 2016
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid

Study Results

No Results Posted as of May 18, 2016