Specimen Collections From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
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| First Received Date ICMJE | November 22, 2000 | ||||||||
| Last Updated Date | May 1, 2013 | ||||||||
| Start Date ICMJE | November 2000 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00006518 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 | Specimen Collections From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer | ||||||||
| Official Title ICMJE | Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-Malignant Lesions, and/or Cancer | ||||||||
| Brief Summary | BACKGROUND: A number of important scientific advances can be made through the study of blood, bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with Kaposi's sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or cancer. This protocol provides a mechanism to effect a variety of such studies. OBJECTIVES: Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from patients with HIV infection, KSHV infection, or with cancer. ELIGIBILITY: Eligibility criteria include age 18 years or older and at lest one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV seropositive; HTLV-1 seropositive; malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma; or cervical or anal intraepithelial lesion. DESIGN: Blood samples may be collected at the initial visit, and at follow-up visits. Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal risk to the patients. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Samples will be studied in the HIV and AIDS Malignancy Branch, CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators. |
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| Detailed Description | BACKGROUND: A number of important scientific advances can be made through the study of blood, bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with Kaposi's sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or cancer. This protocol provides a mechanism to effect a variety of such studies. OBJECTIVES: Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from patients with HIV infection, KSHV infection, or with cancer. ELIGIBILITY: Eligibility criteria include age 18 years or older and at least one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV seropositive; HTLV-1 seropositive; malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma; or cervical or anal intraepithelial lesion. DESIGN: Blood samples may be collected at the initial visit, and at follow-up visits. Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal risk to the patients. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Samples will be studied in the HIV and AIDS Malignancy Branch, CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators. |
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| 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 |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 99999999 | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE |
Age 18 years or older. ECOG performance status less than or equal to 3. At least one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV seropositive; HTLV-1 seropositive; Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma; Cervical or anal intraepithelial lesion; Clinical condition reported or hypothesized to be associated with xenotropic murine leukemia virus-relted virus (XMRV) Patients not requiring biopsy for a medical indication can be included on the study solely for the purpose of obtaining research samples, including blood, pleural fluid, peritoneal fluid, or biopsy samples providing the biopsy or aspiration procedure is of low risk: such procedure include fine needle aspirates, bone marrow aspirate and biopsy, or excisional biopsy. Such biopsies can be completely separate from any other protocol or evaluation process. EXCLUSION CRITERIA: Inability to provide informed consent. |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00006518 | ||||||||
| Other Study ID Numbers ICMJE | 010038, 01-C-0038 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | July 2012 | ||||||||
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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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