Kaposi SarcomaNCT06375122
Natural History Study of Kaposi Sarcoma
An observational study of Kaposi Sarcoma and HIV, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kaposi Sarcoma, HIV
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 31 Dec 2036
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Kaposi sarcoma
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
About this study
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.
Read more
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.
Read the detailed description
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, MCD, or PEL
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.
- Conditions
- Kaposi Sarcoma, HIV
- Keywords
- Kaposi Sarcoma, Samples and data collection, Longitudinal clinical evaluations
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with Kaposi sarcoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 years
Secondary outcomes (2)
To evaluate differences in rates of KS recurrence by human immunodeficiency virus (HIV) status and CD4 T cell count
Assess the proportion of recurrence by HIV status and by CD4 T cell count.
Measured: 10 years
To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start15 May 2024
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ramya M Ramaswami, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375122
- Sponsor's protocol ID
- 10001951
- Other IDs
- 001951-C
- Status last verified
- 13 Oct 2026
- First submitted
- 18 Apr 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25843728Robbins 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.
PubMed 25663691Ballon 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.
PubMed 25607954