Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
研究概览
详细说明
This is a prospective, nonrandomized, open-label, single arm, cohort study of pathologically confirmed HIV-associated KS patients initiating chemotherapy in Malawi. The primary objective of this study is to estimate the complete response rate (CR by ACTG criteria) at 48 weeks. This will be done both overall and by chemotherapy (BV or not BV) treatment group. Secondary objectives are to estimate PFS and OS for both overall and by chemotherapy treatment group. Exploratory objectives include the investigation of: select clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS; the histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients; KSHV strains in tumor biopsies, PBMC and plasma, and KSHV gene expression characteristics between KS that develops on and off ART.
The investigators plan to accrue 200 HIV-associated KS patients at a rate of approximately 50 patients per year. Approximately half of the patients will receive BV chemotherapy treatment. An important factor for this study's size is that it will be comparable to or exceed the size of other important KS cohort studies, which have demonstrated significant differences in outcomes based on gender or baseline KSHV DNA levels.
The investigators want to show that there are definable biologic and clinical subsets within the HIV-associated KS population, and that identifying these subsets will have direct relevance to more effective treatment strategies for these patients.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Lilongwe、马拉维
- UNC Project
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Lilongwe、马拉维
- UNC Project, Lighthouse Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Histologically confirmed KS initiating chemotherapy at Lighthouse Trust or the Kamuzu Central Hospital (KCH) Cancer Clinic
- HIV positive (confirmed at any time point prior by local standard of care assay) on or off ART
- Age ≥18 years
- Residence <200 kilometers from KCH
- Able to understand and comply with study procedures for the entire length of the study
- Subject able to understand and provide written consent in English or Chichewa Informed consent reviewed and signed by patient
Exclusion Criteria:
- Failure to meet inclusion criteria listed above.
- Specifically, pregnancy and breastfeeding are not exclusion criteria given the observational nature of the study with diagnostic and treatment interventions administered according to local standards of care.
- KS relapse disease as defined by a prior KS diagnosis within 1 year prior to enrollment.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Estimate the complete response rate (CR) at 48 weeks of HIV-associated KS patients overall and by BV treatment group.
大体时间：48 weeks
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the assessment of a patient's response (CR) to chemotherapy at 48 weeks by ACTG criteria
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48 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Estimate the Progression Free Survival (PFS) in HIV-associated KS patients overall and by bleomycin-vincristine (BV) treatment group
大体时间：48 weeks
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PFS which will be defined as the time from treatment initiation until disease progression or death
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48 weeks
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Estimate OS in HIV-associated KS patients overall and by BV treatment group
大体时间：48 weeks
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To estimate OS in HIV-associated KS patients overall and by BV treatment group
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48 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS
大体时间：48 weeks
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The prevalence and nature of lymphoproliferative diseases among HIV-associated KS patients
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48 weeks
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The histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients
大体时间：48 weeks
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KSHV gene expression characteristics for HIV-associated KS that develops on and off antiretroviral therapy (ART)
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48 weeks
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The kind of KSHV strains in tumor biopsies, PBMC and plasma
大体时间：48 weeks
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Viral genome features of HIV-associated KS
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48 weeks
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The KSHV gene expression characteristics between KS that develops on and off ART
大体时间：48 weeks
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To describe KSHV gene expression characteristics between KS that develops on and off ART
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48 weeks
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合作者和调查者
调查人员
- 首席研究员：Dirk Dittmer、UNC-CH
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- LCCC 1424
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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