RecruitingNCT04968288

Natural History of KSHV-Associated Multicentric Castleman s Disease

Natural History Study of KSHV-Associated Multicentric Castleman's Disease


Sponsor

National Cancer Institute (NCI)

Enrollment

195 participants

Start Date

Nov 17, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is following the natural course of a rare disease called KSHV-associated Multicentric Castleman Disease (MCD) — a serious inflammatory condition linked to a virus (KSHV, related to the herpes family) that causes enlarged lymph nodes and severe systemic symptoms. The goal is to better understand how it progresses and responds to treatment. **You may be eligible if...** - You have been diagnosed with KSHV-associated Multicentric Castleman Disease, confirmed by biopsy at the study laboratory - You are 18 years or older - You are able to perform basic self-care (ECOG performance status 4 or below) - You are willing and able to provide written informed consent - You may also be enrolled in other studies at the same time **You may NOT be eligible if...** - You are pregnant - You have conditions that would make study participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04968288


Related Trials