Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
Recruiting · NCT00006518 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Cancer Institute (NCI)
View the official record on ClinicalTrials.gov →What this trial is about
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 affect a variety of such studies. OBJECTIVES: -Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants 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: * Up to 999 subjects will be enrolled in this study. * Blood samples may be collected at the initial visit, and at follow-up visits. * Other fluids/excretions may be collected (such as urine, saliva, semen, and stool). * 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 participants. * 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.
Who can take part
Inclusion criteria
- 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
- NOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if participants have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma \[PEL\], or KSHV-multicentric Castleman s disease \[MCD\]), this is sufficient to meet this criterion for eligibility.
- Malignancy, MCD, or skin lesions with appearance of KS
- Cervical or anal intraepithelial lesion
- Ability of participant to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- None
Where it is running
1 location listed across 1 US state.
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States