Actively Recruiting

Age: 18Years - 120Years
All Genders
NCT06375122

Natural History Study of Kaposi Sarcoma

Led by National Cancer Institute (NCI) · Updated on 2026-04-20

150

Participants Needed

1

Research Sites

659 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Natural History Study of Kaposi Sarcoma

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have histologically confirmed Kaposi sarcoma by the Laboratory of Pathology, NCI
  • Presence of cutaneous or oral KS lesions or other assessable KS disease
  • Age 18 years or older
  • ECOG performance status of 4 or less
  • Ability and willingness to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Participants with active KSHV-associated inflammatory cytokine syndrome (KICS), multicentric Castleman disease (MCD), or primary effusion lymphoma (PEL)
  • Participants with serious or uncontrolled severe illness such as opportunistic infections that would prevent study participation according to investigator judgment

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

I

Irene B Ekwede, R.N.

CONTACT

R

Ramya M Ramaswami, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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