Studying Biomarkers as a Diagnostic Tool in Samples From Younger Patients With B-Cell Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01540578
First received: February 22, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

RATIONALE: Finding specific biomarkers may help improve the treatment of patients with B-cell acute lymphoblastic leukemia.

PURPOSE: This clinical trial is studying biomarkers as a diagnostic tool in samples from younger patients with B-cell acute lymphoblastic leukemia.


Condition Intervention
Leukemia
Genetic: fluorescence in situ hybridization
Genetic: microarray analysis
Other: diagnostic laboratory biomarker analysis
Other: flow cytometry
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Replication-timing changes as a biomarker for further risk prediction [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Fresh and frozen bone marrow cells


Estimated Enrollment: 70
Study Start Date: February 2012
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
Archived cell samples are analyzed for replication timing by flow cytometry, microarray analysis, and single-cell fluorescence in situ hybridization (FISH) assays. Replication-timing results among cases and controls are also analyzed by diagnostic laboratory biomarker analysis.
Genetic: fluorescence in situ hybridization
Correlative studies
Genetic: microarray analysis
Correlative studies
Other: diagnostic laboratory biomarker analysis
Correlative studies
Other: flow cytometry
Correlative studies
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

  • To determine whether we can identify individuals within a specific sub-group of pre-B acute lymphoblastic leukemia (ALL) patients that will eventually recur.
  • To identify replication-timing changes as a biomarker for further risk prediction.
  • To identify differences between patients of similar subtype, and choose candidate differences to analyze by methods that are compatible with frozen samples.

OUTLINE: Archived cell samples are analyzed for replication timing by flow cytometry, microarray, and single-cell fluorescence in situ hybridization (FISH) assays. Replication-timing results among cases and controls are also analyzed.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with B-cell acute lymphoblastic samples banked at the COG Cell Bank

Criteria

DISEASE CHARACTERISTICS:

  • Frozen viable cell samples from patients with B-cell acute lymphoblastic (ALL) of any outcome from the Children's Oncology Group (COG) ALL Cell Bank (Part 1)
  • Fresh and frozen cell samples from patients with B-cell ALL with known outcomes from the COG ALL Cell Bank (Part 2) meeting 1 of the following criteria:

    • Samples from patients who experienced an early recurrence within 36 months of diagnosis (cases)
    • Samples from patients who remain in prolonged remission (controls)
  • No samples meeting either of the following criteria:

    • Very-high-risk features

      • Philadelphia chromosome positive
      • Hypodiploid
      • MLL (11q23) rearranged
    • Known favorable risk factors

      • Hyperdiploid
      • t(12;21) (ETV6/RUNX1)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540578

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: David M. Gilbert, MD Florida State University
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01540578     History of Changes
Other Study ID Numbers: AALL12B3, COG-AALL12B3, CDR0000726704
Study First Received: February 22, 2012
Last Updated: June 3, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Burkitt Lymphoma
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoma, B-Cell
Neoplasms, Experimental
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014