Natural History Study of Kaposi Sarcoma

NCT06375122 | Recruiting

• 2 other identifiers: 10001951001951-C
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

HIV; Kaposi Sarcoma

Keywords

Kaposi Sarcoma; Samples and data collection; Longitudinal clinical evaluations

Outcome Measures

Primary Outcomes (1)

• 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

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

  10 years

Secondary Outcomes (2)

• To evaluate differences in rates of KS recurrence by human immunodeficiency virus (HIV) status and CD4 T cell count

  10 years

• To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS

  10 years

Study Arms (1)

Cohort 1

Participants with Kaposi sarcoma

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with Kaposi sarcoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Bhutani M, Polizzotto MN, Uldrick TS, Yarchoan R. Kaposi sarcoma-associated herpesvirus-associated malignancies: epidemiology, pathogenesis, and advances in treatment. Semin Oncol. 2015 Apr;42(2):223-46. doi: 10.1053/j.seminoncol.2014.12.027. Epub 2014 Dec 31.

  PMID: 25843728 BACKGROUND

• Robbins HA, Pfeiffer RM, Shiels MS, Li J, Hall HI, Engels EA. Excess cancers among HIV-infected people in the United States. J Natl Cancer Inst. 2015 Feb 6;107(4):dju503. doi: 10.1093/jnci/dju503. Print 2015 Apr.

  PMID: 25663691 BACKGROUND

• Ballon G, Akar G, Cesarman E. Systemic expression of Kaposi sarcoma herpesvirus (KSHV) Vflip in endothelial cells leads to a profound proinflammatory phenotype and myeloid lineage remodeling in vivo. PLoS Pathog. 2015 Jan 21;11(1):e1004581. doi: 10.1371/journal.ppat.1004581. eCollection 2015 Jan.

  PMID: 25607954 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Sarcoma, Kaposi

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Study Officials

• Ramya M Ramaswami, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene B Ekwede, R.N.

CONTACT

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

Ramya M Ramaswami, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 19, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2036
• Last Updated: April 20, 2026

Record last verified: 2026-04-16

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)