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NCT04968288 · ClinicalTrials.gov registry record
Natural History of KSHV-Associated Multicentric Castleman s Disease
A clinical trial of Multicentric Castleman s Disease, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- 195
- Enrollment target
- 1
- Study location
NCT04968288: Recruiting study of Multicentric Castleman s Disease, sponsored by National Cancer Institute (NCI).
NCT04968288 is a study of Multicentric Castleman s Disease that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 195 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04968288, a study of Multicentric Castleman s Disease, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- 195 participants
- Enrollment target
- 1
- Study location
Study 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, p
Primary Outcome
clinical presentation, patterns of disease progression, therapeutic response, disease recurrence and participant overall survival
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2035-01-01 |
What NCT04968288 shows while recruiting
NCT04968288 is an observational study that tracks outcomes without assigning an intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Multicentric Castleman s Disease appearing as the primary indexed condition, and to 0 interventions.
NCT04968288 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04968288 about?
NCT04968288 is a clinical study titled "Natural History of KSHV-Associated Multicentric Castleman s Disease". 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 caus...
What is the current status of trial NCT04968288?
This trial is currently recruiting. The enrollment target is 195 participants. The study started on 2021-11-17. Estimated completion is 2035-01-01.
What conditions does trial NCT04968288 study?
This clinical trial studies the following conditions: Multicentric Castleman s Disease.
Who is sponsoring clinical trial NCT04968288?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04968288 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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