RECRUITING

Natural History Study of Kaposi Sarcoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Natural History Study of Kaposi Sarcoma

Quick Facts

Study Start:2024-05-15
Study Completion:2036-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06375122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * KS as assessed by cutaneous or oral KS lesions or other assessable KS disease.
  2. * Age \>=18 years.
  3. * ECOG performance status \<=4.
  4. * Ability of participant to understand and the willingness to sign a written informed consent document.
  1. * Participants with active KSHV-associated inflammatory cytokine syndrome (KICS), multicentric Castleman disease (MCD), or primary effusion lymphoma (PEL).
  2. * 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.

Contacts and Locations

Study Contact

Irene Ekwede, R.N.
CONTACT
(240) 760-6126
irene.ekwede@nih.gov
Ramya M Ramaswami, M.D.
CONTACT
(240) 506-1088
ramya.ramaswami@nih.gov

Principal Investigator

Ramya M Ramaswami, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Ramya M Ramaswami, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

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

Study Start Date2024-05-15
Study Completion Date2036-12-31

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2036-12-31

Terms related to this study

Keywords Provided by Researchers

  • Kaposi Sarcoma
  • Samples and data collection
  • Longitudinal clinical evaluations

Additional Relevant MeSH Terms

  • Kaposi Sarcoma
  • HIV