Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma Under 1st and 2nd Lines of Immunotherapy
Multi-centre, Retrospective, Open Label Study, to Establish and Validate ML-PrediCare for Patients of Advanced Melanoma Undergoing Immunotherapy, as a 1st, 2nd and Later Lines
研究概览
详细说明
The aim of this project is to develop a technology application (termed ML-PrediCare), which is meant to be a predictive stand-alone software device, to support clinicians' decision-making, by predicting the individual patient's response to immunotherapy treatments, e.g., in terms of time-to-progression (TTP).
In Stage I of the study, data will be collected for establishing a training set and assess the predictive potential of the modelling technology for the response of melanoma patients to immunotherapy. In Stage II of the study, data will be collected in order to establish a validation set and test the predictive power of the modelling technology in an independent set of patients diagnosed with melanoma.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Bene-Atarot、以色列、60991
- 招聘中
- Optimata Ltd.
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接触：
- Marina Kleiman, PhD
- 电话号码：112 972-751-9226
- 邮箱：marina@optimata.com
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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:
Patients who meet all of the following criteria are eligible for this study:
- Gender: Female, Male.
- Age: Eighteen years and older at the start of treatment.
- Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.
- Prior radiotherapy must have been completed at least 2 weeks prior to drug administration.
- Measurable disease by CT, or PET-CT, or MRI per RECIST 1.1
- Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) before treatment.
- Patient has at least one quantitative measurement of at least one target lesion (primary tumor or metastasis) during or after the treatment.
- Patient has at least one recorded visit to the treating oncologist before treatment.
- Patient has at least one recorded visit to the treating oncologist during or after the treatment.
- Treatment as per SOC for melanoma.
Exclusion Criteria:
Patients meeting one or more of the following criteria are ineligible for this study:
History of another malignancy within the previous 2 years except for:
• Adequately treated Stage I or II cancer currently in complete remission, or any other cancer that has been in complete remission for at least 2 years
- Ocular melanoma
- Active brain metastases or leptomeningeal metastases.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Training Set
The objective of the Training stage is to assess the predictive potential of ML-PrediCare for melanoma patients' response to Ipilimumab, Pembrolizumab and Nivolumab.
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Validation Set
The objective of the Validation stage is to test the predictive power of ML -PrediCare in an independent set of patients diagnosed with melanoma.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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The primary endpoint in this study stage is Time to Progression of disease
大体时间：1 year
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1 year
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合作者和调查者
调查人员
- 研究主任：Marina Kleiman, PhD、Optimata Ltd.
- 首席研究员：Michal Lotem, MD、Hadassah Medical Organization
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
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.
ML-PrediCare的临床试验
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Optimata Ltd.未知
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Shaheed Zulfiqar Ali Bhutto Medical University完全的
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Dr Cipto Mangunkusumo General Hospital主动，不招人
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Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Shanghai Public Health Clinical Center; Air Force Military Medical University, China; Tianjin... 和其他合作者完全的