NCT01490801

Brief Summary

RATIONALE: Studying samples of blood and tissue 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 studies biomarkers in blood and tissue samples from patients with Epstein-Barr virus positive Hodgkin lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
4.4 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

4.4 years

First QC Date

December 9, 2011

Last Update Submit

May 13, 2016

Conditions

Keywords

childhood Hodgkin lymphomachildhood mixed cellularity Hodgkin lymphomahemophagocytic lymphohistiocytosisEpstein-Barr virus infection

Outcome Measures

Primary Outcomes (3)

  • Presence of germline ITK mutations

  • Influence of ITK mutations on total expression levels or intracellular localization of the ITK protein

  • Correlation between ITK mutations with specific clinical or histopathological features of HL

Interventions

Eligibility Criteria

AgeUp to 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of Hodgkin lymphoma.

DISEASE CHARACTERISTICS: * Diagnosis of Hodgkin lymphoma (HL) meeting the following criteria: * Epstein-Barr virus-positive (EBV+) HL as assessed by positive EBV serology, elevated levels of EBV genome in the blood or tumor tissue following quantitative polymerase chain reaction (PCR) and/or evidence of EBV positivity of pathology samples (EBER+ or LMP+) and, when possible, mixed cellular histology * Young age (\< 10 years) at diagnosis * Presence of hemophagocytic lymphohistiocytosis (HLH) 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

Blood and Tissue

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphohistiocytosis, HemophagocyticEpstein-Barr Virus Infections

Interventions

Cytogenetic AnalysisIn Situ HybridizationPolymerase Chain ReactionBlotting, WesternFlow CytometryImmunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHistiocytosis, Non-Langerhans-CellHistiocytosisHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Intervention Hierarchy (Ancestors)

Cytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesStaining and LabelingHistocytological Preparation TechniquesHistological TechniquesNucleic Acid HybridizationNucleic Acid Amplification TechniquesElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesCell SeparationCytophotometryFluorometryLuminescent MeasurementsPhotometryHistocytochemistry

Study Officials

  • Kim E. Nichols, MD, BA

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 9, 2011

First Posted

December 13, 2011

Study Start

December 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05