Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06375122

Conditions

Kaposi Sarcoma

HIV

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Kaposi Sarcoma

HIV

Study ID

NCT06375122

Start date

May 15, 2024

Status verified date

Aug 27, 2026

Completion date

Dec 31, 2036

Anticipated

Primary completion date

Dec 31, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Participants with Kaposi sarcoma

Primary outcome measure

  • 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 [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Irene B Ekwede, R.N.

(240) 760-6126irene.ekwede@nih.gov

Ramya M Ramaswami, M.D.

(240) 506-1088ramya.ramaswami@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

National Cancer Institute Referral Office

888-624-1937ncimo_referrals@mail.nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 1, 2026

Last verified

Aug 27, 2026

Keywords

  • Kaposi Sarcoma
  • Samples and data collection
  • Longitudinal clinical evaluations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-01.