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Studying Patients With a Personal or Family History of Cancer Caused by a Virus

This study is currently recruiting participants.
Study NCT00556582.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Studying Patients With a Personal or Family History of Cancer Caused by a Virus
Official Title  Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers
Brief Summary

RATIONALE: Gathering information about patients with a personal or family history of cancer associated with a virus may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying patients with a personal or family history of cancer caused by a virus.

Detailed Description

OBJECTIVES:

  • Conduct clinical, laboratory, and epidemiologic studies of patients with a personal or family history of viral-associated cancer.

OUTLINE: Patients undergo an interview, physical examination, and blood sample collection. Other clinically indicated biological samples, such as urine, sputum, saliva, tears, or semen or cervical, anal, oral, or nasal swabs, are collected. Skin testing with conventional, licensed antigens for assessment of cellular immunity may be performed, and skin lesions may be biopsied or excised. Tumor or other tissue biopsies may be obtained when biopsy or surgery is clinically indicated. The biological samples are frozen or preserved for current or future research studies.

Patients receive counseling relevant to the disease under study, and about the interim study results. Clinical referrals are made as needed.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure  Clinical, laboratory, and epidemiologic studies of patients with a personal or family history of viral-associated cancer
Secondary Outcome Measure 
Condition  Lymphoma
Lymphoproliferative Disorder
Sarcoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Intervention  Procedure: biologic sample preservation procedure
Procedure: biopsy
Procedure: cytology specimen collection procedure
Procedure: immunologic technique
Procedure: study of high risk factors
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  200
Start Date  December 1996
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Personal or family history of viral-associated neoplasia of an unusual type, pattern, or number including, but not limited to, the following:

    • Kaposi sarcoma
    • Leukemia
    • Lymphoma
  • Known or suspected factor(s) predisposing to neoplasia, including any of the following:

    • Environmental exposure (particularly immunological or virological exposure)
    • Genetic or congenital factors (e.g., Mendelian traits predisposing to neoplasia, birth defects, or chromosomal anomalies)
    • Unusual demographic features
  • Referred to the National Cancer Institute (NCI) Viral Epidemiology Branch

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Gender Both
Ages up to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00556582
Organization ID CDR0000566031
Secondary IDs †† NCI-97-C-0028
Study Sponsor  NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators 
Principal Investigator:     James J. Goedert, MD     National Cancer Institute (NCI)    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2008
First Received Date  November 9, 2007
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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