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

This study is not yet open for participant recruitment.
Verified February 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01540578
First received: February 22, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  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: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 70
Study Start Date: February 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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
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
National Cancer Institute (NCI)
Investigators
Principal Investigator: David M. Gilbert, MD Florida State University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01540578     History of Changes
Other Study ID Numbers: CDR0000726704, COG-AALL12B3
Study First Received: February 22, 2012
Last Updated: February 22, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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 May 16, 2013