NCT01540578

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.2 years

First QC Date

February 22, 2012

Last Update Submit

May 17, 2016

Conditions

B-cell Childhood Acute Lymphoblastic LeukemiaChildhood Acute Lymphoblastic Leukemia in RemissionRecurrent Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Replication-timing changes as a biomarker for further risk prediction by FISH

    2 months

Study Arms (1)

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

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Observational

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh and frozen bone marrow cells

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • David Gilbert, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

February 29, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

US(1)