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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
DNA Virus Infections
Epstein-Barr Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Experimental
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014