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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01490801
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : May 17, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment
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

Detailed Description:


  • 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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's Lymphoma
Study Start Date : December 2011
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Primary Outcome Measures :
  1. Presence of germline ITK mutations
  2. Influence of ITK mutations on total expression levels or intracellular localization of the ITK protein
  3. Correlation between ITK mutations with specific clinical or histopathological features of HL

Biospecimen Retention:   Samples With DNA
Blood and Tissue

Information from the National Library of Medicine

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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.


  • 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)


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01490801

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

Responsible Party: Children's Oncology Group 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) )
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 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:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases