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Natural History Study of Kaposi Sarcoma
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:
🦠 Kaposi Sarcoma 🦠 HIV
🗓️ Study Start (Actual) 15 May 2024
🗓️ Primary Completion (Estimated) 31 December 2034
✅ Study Completion (Estimated) 31 December 2036
👥 Enrollment (Estimated) 150
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Bethesda, Maryland, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 120 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 April 2024
  • First Submitted that Met QC Criteria 18 April 2024
  • First Posted 19 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 July 2024
  • Last Update Posted 25 July 2024
  • Last Verified 23 July 2024
I'm interested ...!!