A Data Collection Study for Patients With Adenocarcinoma Treated With the MyVaccx Immunotherapy Regimen.

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合作者:

信息的提供 (责任方):

，

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

April 11, 2018

预计主要完成日期

July 27, 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

MyVaccx immunotherapy treatment impact on late stage cancer disease[ Time Frame: From date of treatment until the date of death from any cause up to 60 months ]

Time to death after the start of treatment

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

MyVaccx immunotherapy treatment impact on late stage cancer disease[ Time Frame: Time to progression after a complete or partial response up to 60 months ]
Complete and partial response to treatment based on the iRESIST criteria

描述性信息

简略标题 ^ICMJE

A Data Collection Study for Patients With Adenocarcinoma Treated With the MyVaccx Immunotherapy Regimen.

正式标题 ^ICMJE

A Retrospective and Prospective Study of a New Immunotherapy Regimen (MyVaccx) for Patients With Adenocarcinoma.

简要概况

A retrospective and prospective data collection study on 17 consecutive subjects with adenocarcinoma who were treated using the MyVaccx system by Dr. Gary Onik. Retrospective data was collected on the treatment with the immunotherapy system and prospective data will be collected as they are prospectively monitored through their normal standard of care for their original cancer.

详细说明

研究类型 ^ICMJE

Observational

研究阶段

研究设计 ^ICMJE

分配:
干预模型:
干预模型描述:
盲法: Observational
盲法描述:
主要目的:

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Immunotherapeutic Agents
Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents
Device: Ablation
Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents

研究工具

: Adenocarcinoma treated with MyVaccx
MyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease..

招募信息

招募状态 ^ICMJE

Active, not recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 31, 2025

预计主要完成日期

July 27, 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Treatment with the MyVaccx System - Greater than 18 years of age - Signature of the informed consent Exclusion Criteria: - 2 subjects treated with the MyVaccx System with known visceral disease

性别

参与研究的性别:

All

年龄

最小年龄：19 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: Yes

IPD 共享声明

计划分享 IPD:

Yes

责任方

，

研究赞助商 ^ICMJE

Gary Onik MD

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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