RecruitingNCT06375122

Natural History Study of Kaposi Sarcoma


Sponsor

National Cancer Institute (NCI)

Enrollment

150 participants

Start Date

May 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking the natural course of Kaposi Sarcoma (KS) — a cancer that often appears as skin lesions and is associated with a herpesvirus — over time in people already diagnosed with the disease. No experimental treatment is being given; researchers are collecting data to better understand how KS progresses. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of Kaposi Sarcoma (confirmed by biopsy at the NIH Lab of Pathology) - You have visible KS lesions on skin, mouth, or other assessable disease - Your overall health allows participation (ECOG ≤ 4) **You may NOT be eligible if...** - You have KSHV-associated inflammatory cytokine syndrome, multicentric Castleman disease, or primary effusion lymphoma alongside KS - You have serious uncontrolled illnesses (like opportunistic infections) that would prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06375122


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