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Biomarkers in Blood and Tissue Samples From Patients With Epstein-Barr Virus-Positive Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01490801
First received: December 9, 2011
Last updated: May 13, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
Lymphoma Nonneoplastic Condition Genetic: DNA analysis Genetic: RNA analysis Genetic: cytogenetic analysis Genetic: in situ hybridization Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: western blotting Other: flow cytometry Other: immunohistochemistry staining method Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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

Biospecimen Retention:   Samples With DNA
Blood and Tissue

Estimated Enrollment: 50
Study Start Date: December 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Evaluate germline DNA from patients with Epstein-Barr virus positive (EBV+) and Hodgkin lymphoma (HL) for inducible T-cell kinase (ITK) mutations.
  • Examine the effects of ITK mutations on expression of the ITK protein.
  • Determine whether ITK mutations correlate with specific clinical or histopathological features of HL.

OUTLINE: Archived blood and tumor tissue samples are analyzed for germline DNA expression and inducible T-cell kinase (ITK) mutations by PCR, IHC, flow cytometry, and western blotting, and EBV-encoded RNA (EBER) using in situ hybridization. Each patient's data, such as date, sex, age, tumor stage and histology at diagnosis, treatment received, response to treatment, development of recurrent disease, date of last follow-up, and outcomes are also collected.

  Eligibility

Ages Eligible for Study:   up to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of Hodgkin lymphoma.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490801

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kim E. Nichols, MD, BA Children's Hospital of Philadelphia
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01490801     History of Changes
Other Study ID Numbers: AHOD12B1
COG-AHOD12B1 ( Other Identifier: Children's Oncology Group )
AHOD12B1 ( Other Identifier: Children's Oncology Group )
NCI-2012-00089 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: December 9, 2011
Last Updated: May 13, 2016

Keywords provided by Children's Oncology Group:
childhood Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma
hemophagocytic lymphohistiocytosis
Epstein-Barr virus infection

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2017