Natural History Study of Kaposi Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To characterize the natural history of Kaposi sarcoma (KS), including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <=
- •Ability of participant to understand and the willingness to sign a written informed consent document.
排除标准
- •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.
研究组 & 干预措施
Cohort 1
Participants with Kaposi sarcoma
结局指标
主要结局
To characterize the natural history of Kaposi sarcoma (KS), including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype
时间窗: 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
次要结局
- To evaluate differences in rates of KS recurrence by human immunodeficiency virus (HIV) status and CD4 T cell count(10 years)
- To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS(10 years)