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NCT00006518From ClinicalTrials.govRecruiting

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

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

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
National Cancer Institute (NCI)
Enrolment target
1,029
Started
6 December 2000
Main results due
Not stated
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 120 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT00006518. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions | Trialion