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Soft Tissue Sarcoma

Kaposi Sarcoma

Irene Ekwede, R.N.

Ramya M Ramaswami, M.D.

National Cancer Institute Referral Office

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.

Background:

* Kaposi sarcoma (KS) is a multicentric angioproliferative tumor caused by Kaposi sarcoma herpesvirus (KSHV) that most frequently involves skin, but can also involve lymph nodes, lungs, and gastrointestinal tract. It is most common in people with human immunodeficiency virus (HIV) or other forms of immune compromise.
* Patients with HIV-associated KS have worse survival than HIV-infected patients without KS.
* KS can occur alone or with other KSHV-associated disorders such as multicentric Castleman disease (MCD), primary effusion lymphoma (PEL), or KSHV-associated inflammatory cytokine syndrome (KICS).
* The natural history of KS is incompletely understood as it occurs in different epidemiologic subtypes (including those with HIV, particularly among individuals with well-controlled HIV and robust CD4 T cell counts, and those who are HIV-negative).
* The longitudinal evaluations along with tissue sample collection, imaging studies, and participant reported outcomes will allow for the development of a better understanding of the natural history of this disease, and the development of the basis for more effective treatments.

Objective:

-To characterize the natural history of KS, including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype

Eligibility:

* Participants with histologically confirmed KS
* Age \>=18 years
* No active KICS or MCD

Design:

* This will be a long-term trial to comprehensively study participants with KS.
* Medical history including HIV characteristics, research specimens such as KS tissue, blood and saliva will be obtained through the course of KS management with specific attention to patterns related to disease recurrence and progression, response to therapies, and duration of response.
* Outcomes and factors that influence the onset and persistence of KS over the natural history of this condition will be explored in collaboration with other centers that treat participants with KS.
* We anticipate accruing 230 participants on this protocol.

Natural History Study of Kaposi Sarcoma

.This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review.

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

Assess the proportion of recurrence by HIV status and by CD4 T cell count.

Evaluate the proportion of participants with the emergence of KICS, MCD and/or PEL during the course of the natural history evaluation. Evaluation of parameters of CBC, acute, hepatic, mineral panels and CRP may provide predictive markers for the emergence of these conditions.

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Eligibility	Organization
Natural History Study of Kaposi Sarcoma	NCT06375122	Kaposi Sarcoma HIV	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Natural History Study of Kaposi Sarcoma	NCT06375122	Kaposi Sarcoma HIV	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Natural History Study of Kaposi Sarcoma	NCT06375122	Kaposi Sarcoma HIV	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for samples and data collection