Natural History Study of Kaposi Sarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
People with Kaposi sarcoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Cohort 1
Trial outcomes
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
Time frame
10 yearsSecondary outcomes
1
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.
Time frame
10 years2
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.
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov