ClinicalTrials.gov record NCT00006518

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective study enrolls adults with HIV, KSHV, certain other viral infections, or related cancers to provide biological samples for research. Participants give blood and may give other fluids; tumor or bone marrow samples may be collected when accessible with minimal risk. Up to 999 people may be enrolled; biopsy procedures require a separate consent. Samples are studied at NCI laboratories and collaborating sites.

What it is studying. To collect and provide blood, bone marrow, tumor, and other tissue samples from people with HIV, KSHV, other oncogenic virus infections, or related cancers for laboratory research.

What the researchers hope to learn. Scientific goals: acquire serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV, KSHV, other oncogenic virus infections, or related cancers; document the proportion of participants contributing each sample type; and make these samples available for laboratory studies at NCI and collaborating laboratories.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description 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 (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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join you would give written informed consent and provide samples: blood at an initial visit and possibly at follow-up visits; other fluids (for example urine, saliva, semen, stool); and, when applicable and low risk, bone marrow or tumor samples. Tumor sampling methods may include fine needle aspirate, removal of pleural or peritoneal fluid, skin punch biopsy, or excisional biopsy only if the tumor is accessible with minimal risk; a separate consent will describe biopsy risks. Samples will be studied by the HIV and AIDS Malignancy Branch, NCI‑Frederick, or collaborating investigators. Follow-up sample collections may be requested over time.

How the study is structured. A prospective observational cohort: participants provide samples at an initial visit and may return for follow-up sampling. Routine collections include blood and other fluids (urine, saliva, semen, stool). Tumor or marrow samples may be obtained by fine needle aspirate, removal of pleural or peritoneal fluid, skin punch biopsy, or excisional biopsy when the lesion is accessible with minimal risk; biopsy risks are covered in a separate consent. Up to 999 participants; samples are analyzed at NCI and collaborating laboratories.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under HIV; Kaposi's Sarcoma; Lymphomas; Multicentric Castleman's Disease; Primary Effusion Lymphoma. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Castleman disease

Clinical trials14 trials listed for Castleman diseaseEvery trial the registry lists for Castleman disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Castleman disease researchLatest monthly update: September 2026. Includes: Unicentric tumor removal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Dec 6, 2000
Target enrollment
1029 participants (estimated)
Last updated on registry
Oct 8, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
National Cancer Institute (NCI)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • National Institutes of Health Clinical CenterRecruiting

    Bethesda, Maryland, 20892 · United States

Terms used on this page · explanations by MedicalUpdates.ai

Eligibility criteria
The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
ECOG performance status
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
INCLUSION CRITERIA
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
EXCLUSION CRITERIA
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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