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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 9, 2007 | ||||
| Last Updated Date | August 20, 2009 | ||||
| Start Date ICMJE | December 1996 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical, laboratory, and epidemiologic studies of patients with a personal or family history of viral-associated cancer | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00556582 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Studying Patients With a Personal or Family History of Cancer Caused by a Virus | ||||
| Official Title ICMJE | 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | up to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00556582 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000566031, NCI-97-C-0028 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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