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

Tracking Information

First Received Date ^ICMJE

December 9, 2011

Last Updated Date

December 14, 2011

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01490801 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Lymphoma
Nonneoplastic Condition

Intervention ^ICMJE

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 Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 9 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01490801

Other Study ID Numbers ^ICMJE

CDR0000719311, COG-AHOD12B1

Has Data Monitoring Committee

Not Provided

Responsible Party

Peter C. Adamson, Children's Oncology Group - Group Chair Office

Study Sponsor ^ICMJE

Children's Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Kim E. Nichols, MD, BA

Children's Hospital of Philadelphia

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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