Clinical trial Recruiting at 1 site Observational Ages 18 to 120

Understanding the natural history of Kaposi Sarcoma

Official title: Natural History Study of Kaposi Sarcoma

Run by National Institutes of Health Clinical Center (CC) · NCT06375122 · Data updated 2026-11-12

This study looks at how Kaposi Sarcoma affects people with weakened immune systems, like those with HIV, by tracking their symptoms and health over time.

Quick facts

Study typeObservational
Ages18 Years to 120 Years
SexAll
Enrollment150 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedMay 15, 2024
Main results expectedDecember 31, 2034
Study endsDecember 31, 2036
Registry record updatedNovember 3, 2026
Trial IDNCT06375122 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older with histologically confirmed Kaposi Sarcoma.

Probably not a fit

Patients with active KSHV-associated inflammatory cytokine syndrome, multicentric Castleman disease, or primary effusion lymphoma may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize the natural history of Kaposi Sarcoma (KS), a tumor associated with the Kaposi sarcoma herpesvirus, particularly in individuals with compromised immunity such as those with HIV. Participants aged 18 and older with histologically confirmed KS will undergo physical exams, blood tests, imaging scans, and possibly biopsies to collect data on the disease's presentation, manifestations, and recurrence rates. The study will also assess the impact of KS on the immune system and overall health through longitudinal evaluations and participant-reported outcomes.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of Kaposi Sarcoma, potentially informing more effective treatments and management strategies for patients.

How similar studies have gone: While the natural history of Kaposi Sarcoma is not fully understood, similar observational studies have provided valuable insights into other cancers, suggesting potential for meaningful findings in this area.

Who can join: the full rules

Show full inclusion / exclusion 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.

EXCLUSION CRITERIA:

* 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.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Ramya M Ramaswami, M.D. — National Cancer Institute (NCI)
  • Study coordinator: Irene B Ekwede, R.N.
  • Email: irene.ekwede@nih.gov
  • Phone: (240) 760-6126

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.