Actively Recruiting
Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
Led by National Cancer Institute (NCI) · Updated on 2026-05-12
140
Participants Needed
1
Research Sites
903 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: \- KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People with KICS can have severe symptoms. They include fever, weight loss, and fluid in the legs or abdomen. People with KICS may also be at risk of getting other cancers associated with KSHV. These cancers include Kaposi sarcoma and lymphoma. Because KICS is a newly identified disease, more information is needed on how the disease works and what can be done to treat it. Objectives: \- To collect genetic and medical information from people with KSHV inflammatory cytokine syndrome. Eligibility: \- Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and symptoms that resemble those caused by KICS. Design: * Participants will have regular study visits. The schedule will be determined by the study researchers. * Participants will provide a complete medical history and have a full physical exam. Blood and urine samples will be collected as well. * People with KICS that requires treatment may get new experimental treatments. These treatments may include antiviral drugs and chemotherapy drugs, depending on the nature of the disease. * Participants will have imaging studies, such as chest x-rays and computed tomography scans, to study the tumors. * Bone marrow and lymph node biopsies may be done to collect tissue samples for study. * Participants who have Kaposi sarcoma will have photographs taken of their lesions.
CONDITIONS
Official Title
Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 18 years
- Any HIV status
- At least two symptoms, laboratory abnormalities, or imaging findings possibly caused by KICS, including fever, fatigue, weight loss, swelling, respiratory or gastrointestinal symptoms, blood cell abnormalities, low albumin, low sodium, lymph node swelling, organ enlargement, or fluid buildup
- C-reactive protein (CRP) level above 3 mg/L
- Evidence of KSHV infection or risk factors such as being an immigrant from an endemic area or male-to-male sexual activity
- Women who can become pregnant and men must agree to use adequate contraception during and after the study
You will not qualify if you...
- Biopsy-proven KSHV-associated multicentric Castleman disease (MCD)
- Pregnancy
- Severe unrelated medical conditions that prevent safe participation or study treatments
- Any condition judged by investigators to make study participation unsafe or inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Anaida Widell
CONTACT
R
Robert Yarchoan, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here