Understanding the natural history of Kaposi Sarcoma
Natural History Study of Kaposi Sarcoma
National Institutes of Health Clinical Center (CC) · NCT06375122
This study looks at how Kaposi Sarcoma affects people with weakened immune systems, like those with HIV, by tracking their symptoms and health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06375122 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the natural history of Kaposi Sarcoma (KS), a tumor associated with the Kaposi sarcoma herpesvirus, particularly in individuals with compromised immunity such as those with HIV. Participants aged 18 and older with histologically confirmed KS will undergo physical exams, blood tests, imaging scans, and possibly biopsies to collect data on the disease's presentation, manifestations, and recurrence rates. The study will also assess the impact of KS on the immune system and overall health through longitudinal evaluations and participant-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed Kaposi Sarcoma.
Not a fit: Patients with active KSHV-associated inflammatory cytokine syndrome, multicentric Castleman disease, or primary effusion lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of Kaposi Sarcoma, potentially informing more effective treatments and management strategies for patients.
How similar studies have performed: While the natural history of Kaposi Sarcoma is not fully understood, similar observational studies have provided valuable insights into other cancers, suggesting potential for meaningful findings in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: Participants must have histological KS confirmed by the Laboratory of Pathology (LP), NCI. * KS as assessed by cutaneous or oral KS lesions or other assessable KS disease. * Age \>=18 years. * ECOG performance status \<=4. * Ability of participant to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: * Participants with active KSHV-associated inflammatory cytokine syndrome (KICS), multicentric Castleman disease (MCD), or primary effusion lymphoma (PEL). * Participants with serious and/or uncontrolled severe intercurrent illness, such as opportunistic infections, that in the judgement of the investigator would preclude participation in the study.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Ramya M Ramaswami, M.D. — National Cancer Institute (NCI)
- Study coordinator: Irene B Ekwede, R.N.
- Email: irene.ekwede@nih.gov
- Phone: (240) 760-6126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kaposi Sarcoma, HIV, Samples and data collection, Longitudinal clinical evaluations