NCT04968288Recruiting
Natural History of KSHV-Associated Multicentric Castleman s Disease
Natural History Study of KSHV-Associated Multicentric Castleman's Disease
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
Background: Kaposi s sarcoma herpes virus (KSHV) causes several kinds of cancer, Kaposi sarcoma (KS), a form of Multicentric Castleman s Disease (MCD) and a type of lymphoma known as Primary Effusion Lymphoma (PEL). These cancers can occur alone or at the same time in the same patient. MCD can cause a lot of symptoms and problems with various organs in the body, making patients feel quite unwell. If unrecognized, the disease can be fatal. Medications such as rituximab alone or in combination with chemotherapy may help treat MCD but there is little known about the long term effects and the natural course of MCD. Objective: To better understand the biology of KSHV-MCD to help identify how this disease causes illness and how cancer treatments known to be effective in MCD may help patients with this condition. This study also aims to help identify ways to treat the disease by providing other standard cancer treatments that would be useful to use to treat MCD based on what we know about this condition. Eligibility: People 18 years of age and older with KSHV-MCD. Design: Participants will be screened with: Medical history Physical exam CT scan Blood and heart tests Participants will have an initial evaluation. This will include: Review of participants symptoms and ability to perform their normal activities Blood and urine tests Imaging studies such as CT and PET scans. Participants may have a contrast agent injected into their arm. Photographs to document skin lesions Optional skin biopsy. For this, a small piece of the skin will be removed. Optional lymph node needle biopsy Optional samples of the fluid in the space around the lungs, intestines, or heart Optional sample of the liquid that surrounds the brain and spinal cord Saliva samples DEXA scan to examine the bones Questionnaires Optional limb measurements or cognitive tests Physicians will give participants recommendations about treatment. After their initial evaluation and any treatment, participants will have additional visits. These will occur every 3 months for the first year, then every 6 months for the second year, and then once a year for up to 1 year.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 195 (estimated)
- First submitted
- 17 Jul 2021
- Start date
- 17 Nov 2021
- Primary completion date
- 1 Jan 2034
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Sarcoma
- NCT number
- NCT04968288
What you commit to
- Study type: Observational
- Planned participants: 195
- From 17 Nov 2021 to the primary completion date, 1 Jan 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individual.
Other
- Pregnancy
Criteria the registry did not label
- INCLUSION CRITERIA:
- Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology (LP), CCR
- Age \>=18 years.
- ECOG performance status \<=4 (Karnofsky \>=20%).
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Participants may be co-enrolled in other protocols, including investigational studies to treat KSHV-associated malignancies.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.