Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01490801
First received: December 9, 2011
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  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
Official Title: Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's Lymphoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Presence of germline ITK mutations [ Designated as safety issue: No ]
  • Influence of ITK mutations on total expression levels or intracellular localization of the ITK protein [ Designated as safety issue: No ]
  • Correlation between ITK mutations with specific clinical or histopathological features of HL [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Primary Completion Date: February 2012 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01490801     History of Changes
Other Study ID Numbers: CDR0000719311, COG-AHOD12B1
Study First Received: December 9, 2011
Last Updated: December 14, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma
hemophagocytic lymphohistiocytosis
Epstein-Barr virus infection

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

ClinicalTrials.gov processed this record on May 16, 2013