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Natural History Study of Kaposi Sarcoma

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ClinicalTrials.gov Identifier: NCT06375122
Recruitment Status : Recruiting
First Posted : April 19, 2024
Last Update Posted : June 10, 2024
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date April 18, 2024
First Posted Date April 19, 2024
Last Update Posted Date June 10, 2024
Actual Study Start Date May 15, 2024
Estimated Primary Completion Date December 31, 2034   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2024)
To characterize the natural history of KS, including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype [ Time Frame: 10 years ]
Assessment of the proportion of participants with KS by epidemiologic subtype who experience remission and recurrent KS over the course of the disease
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 18, 2024)
  • To evaluate differences in rates of KS recurrence by HIV status and CD4 T cell count [ Time Frame: 10 years ]
    Assess the proportion of recurrence by HIV status and by CD4 T cell count.
  • To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS [ Time Frame: 10 years ]
    Evaluate the proportion of participants with the emergence of KICS, MCD and/or PEL during the course of the natural history evaluation. Evaluation of parameters of CBC, acute, hepatic, mineral panels and CRP may provide predictive markers for the emergence of these conditions.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Natural History Study of Kaposi Sarcoma
Official Title Natural History Study of Kaposi Sarcoma
Brief Summary

Background:

Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs.

Objective:

To learn more about the natural history of KS.

Eligibility:

People aged 18 years and older with KS.

Design:

Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed.

Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include:

Eye exam.

Ultrasound exam of the heart (electrocardiogram).

Collection of saliva and urine samples.

Biopsies of the skin or lymph nodes.

Swabs of the anus and cervix.

Photographs of skin lesions.

Removal of fluid samples from the space around the lungs, intestine, or heart.

The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years.

Participants will follow their standard treatment for KS during the study.

Detailed Description

Background:

  • Kaposi sarcoma (KS) is a multicentric angioproliferative tumor caused by Kaposi sarcoma herpesvirus (KSHV) that most frequently involves skin, but can also involve lymph nodes, lungs, and gastrointestinal tract. It is most common in people with human immunodeficiency virus (HIV) or other forms of immune compromise.
  • Patients with HIV-associated KS have worse survival than HIV-infected patients without KS.
  • KS can occur alone or with other KSHV-associated disorders such as multicentric Castleman disease (MCD), primary effusion lymphoma (PEL), or KSHV-associated inflammatory cytokine syndrome (KICS).
  • The natural history of KS is incompletely understood as it occurs in different epidemiologic subtypes (including those with HIV, particularly among individuals with well-controlled HIV and robust CD4 T cell counts, and those who are HIV-negative).
  • The longitudinal evaluations along with tissue sample collection, imaging studies, and participant reported outcomes will allow for the development of a better understanding of the natural history of this disease, and the development of the basis for more effective treatments.

Objective:

-To characterize the natural history of KS, including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype

Eligibility:

  • Participants with histologically confirmed KS
  • Age >=18 years
  • No active KICS or MCD

Design:

  • This will be a long-term trial to comprehensively study participants with KS.
  • Medical history including HIV characteristics, research specimens such as KS tissue, blood and saliva will be obtained through the course of KS management with specific attention to patterns related to disease recurrence and progression, response to therapies, and duration of response.
  • Outcomes and factors that influence the onset and persistence of KS over the natural history of this condition will be explored in collaboration with other centers that treat participants with KS.
  • We anticipate accruing 230 participants on this protocol.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population People with Kaposi sarcoma
Condition
  • Kaposi Sarcoma
  • HIV
Intervention Not Provided
Study Groups/Cohorts Cohort 1
Participants with Kaposi sarcoma
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 18, 2024)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2036
Estimated Primary Completion Date December 31, 2034   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Irene Ekwede, R.N. (240) 760-6126 irene.ekwede@nih.gov
Contact: Ramya M Ramaswami, M.D. (240) 506-1088 ramya.ramaswami@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT06375122
Other Study ID Numbers 10001951
001951-C
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: .This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Original Responsible Party Same as current
Current Study Sponsor National Cancer Institute (NCI)
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Ramya M Ramaswami, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date June 6, 2024