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

May 17, 2016 updated by: Children's Oncology Group

OBSERVATIONAL: Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Monrovia, California, United States, 91006-3776
        • Children's Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Replication-timing changes as a biomarker for further risk prediction by FISH
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David Gilbert, MD, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 29, 2012

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AALL12B3
  • NCI-2012-00685 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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