NCT01553162

Brief Summary

RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

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

First Submitted

Initial submission to the registry

March 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
4.1 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

4.1 years

First QC Date

March 10, 2012

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

B-cell childhood acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (2)

  • Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old

  • Genes that are required for efficient apoptosis

Interventions

DNA analysisGENETIC
RNA analysisGENETIC
gene expression analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia

DISEASE CHARACTERISTICS: * Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia * Samples from patients treated and not treated with Dex and Pred PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative Techniques

Study Officials

  • Miles A. Pufall, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2012

First Posted

March 14, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05