Skip to content

Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer

Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With HIV Infection, KSHV Infection, Viral-Related Pre-Malignant Lesions, and/or Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00006518
Enrollment
1029
Registered
2000-11-23
Start date
2000-12-06
Completion date
Unknown
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Kaposi's Sarcoma, Lymphomas, Multicentric Castleman's Disease, Primary Effusion Lymphoma

Keywords

Tumor, Viruses, HIV, KSHV, AIDS, Natural History

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.

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 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 (KS); or cervical or anal intraepithelial lesion. DESIGN: * Up to 999 participants will be provide samples 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.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.OngoingProportion of participants that have contributed serum, circulating cells, bone marrow, and tumor or normal tissue samples

Countries

United States

Contacts

CONTACTIjeoma M Agwu
ijeoma.agwu@nih.gov(240) 858-7435
CONTACTRobert Yarchoan, M.D.
robert.yarchoan@nih.gov(240) 760-6075
PRINCIPAL_INVESTIGATORRobert Yarchoan, M.D.

National Cancer Institute (NCI)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026