NCT01366157

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research trial is studying protein biomarker levels in tissue samples from young patients with low-risk Hodgkin lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2011

Longer than P75 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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

5 years

First QC Date

June 2, 2011

Last Update Submit

May 13, 2016

Conditions

Keywords

childhood favorable prognosis Hodgkin lymphomastage I childhood Hodgkin lymphomastage II childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomachildhood lymphocyte depletion Hodgkin lymphomachildhood lymphocyte predominant Hodgkin lymphomachildhood mixed cellularity Hodgkin lymphomachildhood nodular lymphocyte predominant Hodgkin lymphomachildhood nodular sclerosis Hodgkin lymphoma

Outcome Measures

Primary Outcomes (4)

  • Variability of HGAL protein expression in pediatric patients with low-risk classical Hodgkin lymphoma (cHL)

  • Variability of HGAL staining between low-risk and intermediate-risk pediatric patients with cHL

  • Variability of HGAL staining as assessed by tissue array in pediatric patients with intermediate-risk cHL

  • Correlation of rapid or slow early response in the intermediate-risk group with HGAL protein expression

Interventions

Eligibility Criteria

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

Diagnosed with low-risk classical Hodgkin lymphoma

DISEASE CHARACTERISTICS: * Diagnosed with low-risk classical Hodgkin lymphoma (cHL) * Samples available from patients enrolled in the low-risk study COG-AHOD0431 and in the intermediate-risk cHL study COG-AHOD0031 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

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

LymphomaHodgkin Disease

Interventions

Microarray AnalysisImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Microchip Analytical ProceduresInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic Techniques

Study Officials

  • Frank G. Keller, MD

    Emory Children's Center - Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
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

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05