软组织肿瘤组织粉碎术前瞻性注册研究
Histotripsy is a treatment that uses focused ultrasound waves to break down tissue without surgery. The ultrasound waves meet at a specific spot and turn the tissue into liquid. This study is a prospective observational registry of participants receiving histotripsy. The goal of this study is to gather information about the use of histotripsy to confirm it is safe and effective medical procedure.
研究概览
详细说明
CURRENTLY ONY ENROLLING PATIENTS AT UCSF REFERRED BY PHYSICIAN.
PRIMARY OBJECTIVES:
- Tumor response on imaging will be assessed using standardized criteria for tumor types such as European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST).
- Progression free survival and overall survival.
- Risk factors for adverse events identified by NCI Common Terminology Criteria for Adverse Events (CTCAE).
OUTLINE:
Researchers will collect data from consenting participants' regular doctor visits via medical records for three years after the Histotripsy procedure has taken place.
研究类型
注册 (估计的)
联系人和位置
学习地点
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California
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San Francisco、California、美国、94143
- University of California, San Francisco
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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
Adult participants diagnosed with soft tissue malignancies receiving care at UCSF who previously received HIFU
描述
CURRENTLY ONY ENROLLING PATIENTS AT UCSF REFERRED BY PHYSICIAN.
Inclusion Criteria:
- All adult patients who are treated with histotripsy per standard clinical care at University of California San Francisco (UCSF) are eligible for inclusion in the registry.
Exclusion Criteria:
- Children/minors, and adults who lack decision-making capacity, will be excluded from the registry. Patients who do not consent for inclusion in the registry will also be excluded.
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_ONLY
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Participants with Soft Tissue Tumors
Participant data will be collected from participants' medical records. Cancer history, laboratory analysis, histotripsy procedure details, adverse events, and oncological outcomes of the procedure along with demographic data will be collected. |
Data will be collected from the participants medical records.
其他名称：
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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 |
|---|---|---|
|
Frequency of overall tumor response across all participants
大体时间：up to 3 years
|
Imaging studies will be conducted to assess for a response across all participants (complete response (CR), Partial response (PR), Stable Disease (SD) and Progressive disease (PD) etc.) using the standardized criteria for tumor response assessment. The standard criteria for European Association for the Study of the Liver (EASL), Response Evaluation Criteria in Solid Tumors (RECIST), and modified RECIST (mRECIST) will be used to determine response depending on the participant's soft tissue tumor type |
up to 3 years
|
|
Proportion of participants experienced an adverse event
大体时间：Up to 3 years
|
Proportion of participants with adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0). Adverse events will be evaluated using multivariate analysis. |
Up to 3 years
|
|
Progression free survival (PFS)
大体时间：up to 3 years
|
The analysis of progression-free survival (PFS) will include all participants who have received histotripsy treatment. PFS is defined as the time from the date of histotripsy treatment to the first documented disease progression or death from any cause, whichever occurs first. PFS will be evaluated using time-to-event analysis methods. |
up to 3 years
|
|
Overall Survival (OS)
大体时间：Up to 3 years
|
The analysis of OS include participants who have received histotripsy treatment. OS is defined as the of treatment to the time of death. OS will be evaluated using time-to-event analysis methods. |
Up to 3 years
|
合作者和调查者
调查人员
- 首席研究员：Ryan Lokken, MD、University of California, San Francisco
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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
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.