Protocol Details
Natural History Study of Kaposi Sarcoma
This study is currently recruiting participants.
Summary
Number |
001951-C |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Children;
Neonates;
Fetuses |
Keywords |
Kaposi Sarcoma;
Samples and data collection;
Longitudinal clinical evaluations |
Recruitment Keyword(s) |
None |
Condition(s) |
Kaposi Sarcoma;
HIV |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Cancer Institute |
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
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.
Citations:
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; PMCID: PMC6309362.
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. PMID: 25663691; PMCID: PMC4334816.
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. PMID: 25607954; PMCID: PMC4301867.
Contacts:
Clinical Trials Number:
NCT06375122