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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00006518 |
Purpose
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.
| Condition |
|---|
|
HIV Infection Kaposi's Sarcoma |
| Study Type: | Observational |
| Official Title: | Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-related Pre-malignant Lesions, and/or Cancer |
| Estimated Enrollment: | 9999 |
| Study Start Date: | November 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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; or Cervical or anal intraepithelial lesion.
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 sepatate from any other protocol or evaluation process.
EXCLUSION CRITERIA:
Inability to provide informed consent.
Contacts and Locations| Contact: NCI Referral Office | 1-888-NCI-1937 | ncicssc@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| National Institute of Dental and Craniofacial Research (NIDCR), 9000 Rockville P | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: Peter Burbelo | |
| National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: Joseph Kovacs | |
More Information
| Study ID Numbers: | 010038, 01-C-0038 |
| Study First Received: | November 22, 2000 |
| Last Updated: | November 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006518 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV KSHV HHV-8 Cancer AIDS |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Neoplasms by Histologic Type Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Infection Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms HIV Infections Sexually Transmitted Diseases Neoplasms, Vascular Tissue Sarcoma Lentivirus Infections DNA Virus Infections Retroviridae Infections |
