Following People with Kaposi Sarcoma to Learn How It Develops
Follows adults with Kaposi sarcoma, a tumor linked to a herpesvirus, over time.
Key facts
- Who runs it
- National Cancer Institute (NCI)
- Where
- Bethesda, United StatesSee the site
- Trial code
- Registry title
- Natural History Study of Kaposi Sarcoma
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 15 May 2024
- Expected to end
- 31 Dec 2036
- Type of study
- Observational
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Kaposi sarcoma confirmed by a tissue test. It follows how the disease develops over time.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Kaposi sarcoma confirmed by tissue examination at the NCI pathology laboratory, with skin or oral lesions or other disease that can be assessed.
Main reasons for not taking part
- Active KSHV-associated inflammatory cytokine syndrome (KICS)
- Multicentric Castleman disease (MCD)
- Primary effusion lymphoma (PEL)
- Serious or uncontrolled severe illness, such as opportunistic infections, that the investigator judges would prevent taking part
The registry criteria, word for word
Show all 7 criteriaShow less
Who cannot take part
- 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
Other criteria
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesContact: National Cancer Institute Referral OfficeTaking people
About the trial
What the trial wants to find out
Background:
Read full original descriptionShow less
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.
The group in the trial
- Cohort 1
Participants with Kaposi sarcoma
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Natural History Study of Kaposi Sarcoma
- Plain-language title
- Following People with Kaposi Sarcoma to Learn How It DevelopsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06375122, who can take part
- Record updated
- 3 November 2026