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

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ClinicalTrials.gov Identifier: NCT01540578
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
This clinical trial is studying biomarkers as a diagnostic tool in samples from younger patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help improve the treatment of patients with B-cell acute lymphoblastic leukemia

Condition or disease Intervention/treatment
B-cell Childhood Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia in Remission Recurrent Childhood Acute Lymphoblastic Leukemia Other: laboratory biomarker analysis

Detailed Description:

STUDY SUBTYPE: Ancillary/Correlative

OBSERVATIONAL STUDY MODEL: Case-only

TIME PERSPECTIVE: Retrospective

BIOSPECIMEN RETENTION: Samples with DNA

BIOSPECIMEN DESCRIPTION: Fresh and frozen bone marrow cells

STUDY POPULATION DESCRIPTION: Patients with B-cell acute lymphoblastic samples banked at the COG Cell Bank

SAMPLING METHOD: Non-probability sample

OBJECTIVES:

I. To determine whether we can identify individuals within a specific sub-group of pre-B acute lymphoblastic leukemia (ALL) patients that will eventually recur.

II. To identify replication-timing changes as a biomarker for further risk prediction.

III. 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.


Study Type : Observational
Actual Enrollment : 70 participants
Time Perspective: Retrospective
Official Title: OBSERVATIONAL: Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)
Study Start Date : February 2012
Actual Primary Completion Date : May 2016


Group/Cohort Intervention/treatment
Observational
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.
Other: laboratory biomarker analysis
Correlative studies



Primary Outcome Measures :
  1. Replication-timing changes as a biomarker for further risk prediction by FISH [ Time Frame: 2 months ]

Biospecimen Retention:   Samples With DNA
Fresh and frozen bone marrow cells


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Inclusion Criteria:

  • 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)
  • Freshand 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540578


Locations
United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Gilbert, MD Children's Oncology Group

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01540578     History of Changes
Other Study ID Numbers: AALL12B3
NCI-2012-00685 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

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