NCT00006518 Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
| NCT ID | NCT00006518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | HIV |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,029 participants |
| Start Date | 2000-12-06 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,029 participants in total. It began in 2000-12-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
* 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
Contact & Investigator
Robert Yarchoan, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT00006518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00006518 currently recruiting?
Yes, NCT00006518 is actively recruiting participants. Contact the research team at anaida.widell@nih.gov for enrollment information.
Where is the NCT00006518 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00006518 clinical trial?
NCT00006518 is sponsored by National Cancer Institute (NCI). The principal investigator is Robert Yarchoan, M.D. at National Cancer Institute (NCI). The trial plans to enroll 1,029 participants.
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