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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01540578

Enrollment

Registered

2012-02-29

Start date

2012-02-29

Completion date

Unknown

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Childhood Acute Lymphoblastic Leukemia, Childhood Acute Lymphoblastic Leukemia in Remission, Recurrent Childhood Acute Lymphoblastic Leukemia

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

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026