Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT00006518

Conditions

HIV

Kaposi's Sarcoma

Lymphomas

Multicentric Castleman's Disease

Primary Effusion Lymphoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

HIV

Kaposi's Sarcoma

Lymphomas

Multicentric Castleman's Disease

Primary Effusion Lymphoma

Study ID

NCT00006518

Start date

Dec 6, 2000

Status verified date

Aug 21, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

1029 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Participants with HIV infection, KSHV infection, or with cancer

Primary outcome measure

  • Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer. [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 31, 2026

Last verified

Aug 21, 2026

Keywords

  • Tumor
  • Viruses
  • HIV
  • KSHV
  • AIDS
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-31.