NCT01366170

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. PURPOSE: This research trial studies biomarker expression in tissue samples from young patients with anaplastic large cell lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7

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

May 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

5 years

First QC Date

June 2, 2011

Last Update Submit

May 17, 2016

Conditions

Lymphoma

Keywords

childhood anaplastic large cell lymphoma

Outcome Measures

Primary Outcomes (2)

  • Expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in ALCL

  • Correlation of CD4, FOXP3, and CD276 with ALK autoantibody response in patients enrolled in ANHL0131

Interventions

microarray analysisGENETIC
protein expression analysisGENETIC
western blottingGENETIC
flow cytometryOTHER
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
mass spectrometryOTHER

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of anaplastic large cell lymphoma.

DISEASE CHARACTERISTICS: * Diagnosis of anaplastic large cell lymphoma * Tissue microarray samples available from the Cooperative Human Tissue Network (CHTN) 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

LymphomaLymphoma, Large-Cell, Anaplastic

Interventions

Microarray AnalysisBlotting, WesternFlow CytometryImmunohistochemistryMass Spectrometry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesCell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryHistocytochemistryHistological Techniques

Study Officials

  • Megan S. Lim, MD, PhD

    C.S. Mott Children's Hospital at University of Michigan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 3, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05