Natural History Study of Kaposi Sarcoma

This study is observing Kaposi sarcoma (KS), a type of tumor caused by a virus, to better understand how it develops, why it might come back, and how it affects the body. Researchers want to learn more about KS in people with and without HIV. You may be able to join if you are 18 years or older and have KS confirmed by a lab. The study aims to follow participants for 10 years to see how KS changes over time, including if it goes away or returns. This information will help doctors understand the disease better and develop more effective treatments in the future. The study is currently recruiting about 150 participants.

Study design
This is an observational study, meaning researchers will watch how Kaposi sarcoma progresses naturally. It aims to enroll about 150 participants.
What's involved
You will have a physical exam, blood tests, and an imaging scan. You may also need a new biopsy where tissue samples are taken from your tumor, and your ability to do normal activities will be assessed.
Compensation
Not stated in the trial record.
Follow-up
The study will characterize the proportion of participants with KS with remission and recurrence by epidemiologic subtype, measured at 10 years.

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NCT06375122

Natural History Study of Kaposi Sarcoma

Recruiting
Not specifiedAges 18+Observational
National Cancer Institute (NCI)
~150 participants
Updated 2026-08-31 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To characterize the natural history of Kaposi sarcoma (KS), including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype
Measured over 10 years
Kaposi Sarcoma
HIV
1 sites across 1 states
Maryland1
  • Ramya M Ramaswami, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • To characterize the natural history of Kaposi sarcoma (KS), including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype10 years

    Assessment of the proportion of participants with KS by epidemiologic subtype who experience remission and recurrent KS over the course of the disease