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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01490801
• Other study ID #: AHOD12B1
• Secondary ID: COG-AHOD12B1AHOD
• Status: Active, not recruiting
• Phase: N/A
• First received: December 9, 2011
• Last updated: May 8, 2015
• Start date: December 2011

Study information

• Verified date: May 2015
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. primary completion date: January 2100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 9 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Nonneoplastic Condition

Intervention

Genetic:
• DNA analysis

• RNA analysis

• cytogenetic analysis

• in situ hybridization

• mutation analysis

• polymerase chain reaction

• western blotting

Other:
• flow cytometry

• immunohistochemistry staining method

• medical chart review

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of germline ITK mutations			No
Primary	Influence of ITK mutations on total expression levels or intracellular localization of the ITK protein			No
Primary	Correlation between ITK mutations with specific clinical or histopathological features of HL			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database