Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375122
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-18
Brief Title:
Natural History Study of Kaposi Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History Study of Kaposi Sarcoma
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001951-C | None | None | None |