- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01490801
Biomarkers in Blood and Tissue Samples From Patients With Epstein-Barr Virus-Positive Hodgkin Lymphoma
Role of the IL-2 Inducible Tcell Kinase in EBV-HLH and EBV+ Hodgkin's 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kim E. Nichols, MD, BA, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHOD12B1 (Other Identifier: Children's Oncology Group)
- COG-AHOD12B1 (Other Identifier: Children's Oncology Group)
- NCI-2012-00089 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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