Collecting samples from patients with HIV and related conditions
Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-Malignant Lesions, and/or Cancer
This study is collecting blood and tissue samples from adults with HIV and related cancers to help researchers learn more about these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1029 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00006518 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood, bone marrow, tumor, and other tissue samples from participants who are infected with HIV, Kaposi's sarcoma-associated herpesvirus (KSHV), or have related cancers. The study will enroll up to 999 subjects aged 18 and older, who meet specific eligibility criteria related to their infection status or cancer diagnosis. Samples will be collected during initial and follow-up visits, and various fluids may also be obtained for analysis. The goal is to facilitate important scientific advances in understanding these conditions through the study of biological specimens.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are HIV or KSHV seropositive, or have related malignancies or lesions.
Not a fit: Patients who are not infected with HIV or KSHV and do not have related cancers or lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to significant advancements in the understanding and treatment of HIV-related malignancies.
How similar studies have performed: Other studies have shown success in utilizing biological samples from similar patient populations to advance scientific knowledge, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Robert Yarchoan, M.D. — National Cancer Institute (NCI)
- Study coordinator: Anaida Widell
- Email: anaida.widell@nih.gov
- Phone: (240) 760-6074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.