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Completed

NCT Number: NCT01490801

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA analysis

Genetic

RNA analysis

Genetic

cytogenetic analysis

Genetic

in situ hybridization

Genetic

mutation analysis

Genetic

polymerase chain reaction

Genetic

western blotting

Genetic

flow cytometry

Other

immunohistochemistry staining method

Other

medical chart review

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's Lymphoma

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2011
Registry last updated
May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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