NCT01581528

Brief Summary

RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors identify learn more about biomarkers related to cancer. It may also help doctors to find better ways to treat cancer. PURPOSE: This research studies samples from patients with T-cell acute lymphoblastic leukemia (T-ALL).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

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

Study Start

First participant enrolled

April 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
4 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

April 19, 2012

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

T-cell childhood acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiaT-cell adult acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (3)

  • Metabolic status of primary T-ALL

  • Effects of metabolic inhibition on metabolic stress pathways and apoptosis

  • Metabolic inhibition interaction with chemotherapy or targeted drugs

Interventions

gene expression analysisGENETIC
cell culture procedureOTHER
flow cytometryOTHER
laboratory biomarker analysisOTHER
metabolic assessmentOTHER

Eligibility Criteria

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

patients diagnosed with T-ALL

DISEASE CHARACTERISTICS: * Sample from patients diagnosed with T-ALL * Samples from independent healthy donors obtained through the Gulf Coast Regional Blood Center (controls) PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

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 ProfilingCell Culture TechniquesFlow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCulture TechniquesIn Vitro TechniquesCell SeparationCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, Analytical

Study Officials

  • Jeffrey C. Rathmell, PhD

    Duke Cancer Institute

    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

April 19, 2012

First Posted

April 20, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05