Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS) (NCT01419561) | Clinical Trial Compass
RecruitingPhase 2
Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
United States140 participantsStarted 2011-09-08
Plain-language summary
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....
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Age greater than or equal to18 Years.
* Any HIV status.
* At least two manifestations drawn from at least two of the categories (clinical symptoms, laboratory abnormalities and/or radiographic abnormalities), which are at least possibly attributable to KICS and are not readily explicable from known medical conditions in the participant:
* Clinical symptoms (each at least grade 1 by CTCAE definitions)
* Fever (\>38 degrees C), chills or rigors
* Fatigue or lethargy
* Cachexia or edema
* Cough, dyspnea, airway hyperreactivity, or nasal inflammation
* Nausea, anorexia, abdominal pain or altered bowel habit
* Athralgia or myalgia
* Altered mental state
* Neuropathy with or without pain
* Laboratory abnormalities
* Anemia (hemoglobin\<12.0g/dL)
* Thrombocytopenia (platelets\<100,000 cells/microL)
* Leukopenia (white cell count\<4,000 cells/microL)
* Hypoalbuminemia (albumin\<3.5g/dL)
* Hyponatremia (sodium\<135mmol/L)
* Coagulopathy (PT or PTT \>1.5 times upper limit of normal)
* Radiographic Abnormalities
* Pathologic lymphadenopathy (at least five discrete nodes each \>1cm in their longest dimension)
* Splenomegaly (\>12 cm in the longest dimension)
* Hepatomegaly (\>17cm in the longest dimension)
* Body cavity effusions not caused by primary effusion lymphoma nor chylous effusions directly related to lymphatic infiltration by KS
* C-reactive protein (CRP) \>3mg/L.
* Exposure risk for KSHV infection (including being a first or second generation immigrant …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.