Fact CheckerSign in

NCT06375122Recruiting

Natural History Study of Kaposi Sarcoma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

Background: Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs. Objective: To learn more about the natural history of KS. Eligibility: People aged 18 years and older with KS. Design: Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed. Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include: Eye exam. Ultrasound exam of the heart (electrocardiogram). Collection of saliva and urine samples. Biopsies of the skin or lymph nodes. Swabs of the anus and cervix. Photographs of skin lesions. Removal of fluid samples from the space around the lungs, intestine, or heart. The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years. Participants will follow their standard treatment for KS during the study.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
18 Apr 2024
Start date
15 May 2024
Primary completion date
31 Dec 2034
Lead sponsor
National Cancer Institute (NCI)
Diseases
HIV, Sarcoma
NCT number
NCT06375122

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 15 May 2024 to the primary completion date, 31 Dec 2034
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants with active KSHV-associated inflammatory cytokine syndrome (KICS), multicentric Castleman disease (MCD), or primary effusion lymphoma (PEL).
  • Participants with serious and/or uncontrolled severe intercurrent illness, such as opportunistic infections, that in the judgement of the investigator would preclude participation in the study.

Criteria the registry did not label

  • INCLUSION CRITERIA:
    • Participants must have histological KS confirmed by the Laboratory of Pathology (LP), NCI.
  • KS as assessed by cutaneous or oral KS lesions or other assessable KS disease.
  • Age \>=18 years.
  • ECOG performance status \<=4.
  • Ability of participant to understand and the willingness to sign a written informed consent document.

Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Institutes of Health Clinical Center
Coordinator of this site? Confirm its status
BethesdaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.