RECRUITING

Natural History of KSHV-Associated Multicentric Castleman s Disease

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 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.

Official Title

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

Quick Facts

Study Start:2021-11-17
Study Completion:2035-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04968288

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology (LP), CCR
  2. * Age \>=18 years.
  3. * ECOG performance status \<=4 (Karnofsky \>=20%).
  4. * Ability of subject to understand and the willingness to sign a written informed consent document.
  5. * Participants may be co-enrolled in other protocols, including investigational studies to treat KSHV-associated malignancies.
  1. * 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.
  2. * Pregnancy

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 Date2021-11-17
Study Completion Date2035-01-01

Study Record Updates

Study Start Date2021-11-17
Study Completion Date2035-01-01

Terms related to this study

Keywords Provided by Researchers

  • Kaposi s sarcoma
  • HIV
  • primary effusion lymphoma
  • interlerleukin-6
  • Natural History

Additional Relevant MeSH Terms

  • Multicentric Castleman s Disease