A Translational Systems Medicine Approach to Provide Predictive Capacity for Therapy Responsiveness in Advanced or Metastatic Malignant Melanoma (SYS-ACT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Validation of SYS-ACT
研究概览
简要总结
This is an exploratory prospective translational multicentre study. Melanoma is the 5th most common cancer diagnosed in Ireland and its incidence among women and men is above the European average.
Following treatment the elimination of cancer cells ultimately occurs by the activation of apoptotic cell death pathways. The SYS-ACT approach builds on a combination of mathematical systems of modelling, quantitative biochemistry and cell biology, and specifically predicts the drug responsiveness of melanoma cell lines to various apoptosis-inducing treatments.
The investigators propose to validate the SYS-ACT approach and application in a translational systems medicine study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age.
- •Patient must be able to give own signed informed consent.
- •Patients that present with advanced or metastatic (stage III/IV) malignant melanoma of the skin.
- •Patients that are planned to receive either:
- •Adjuvant treatment
- •1st line treatment for metastatic disease
- •2nd line treatment for metastatic disease
- •Patients with prior adjuvant treatment are allowed.
- •Patients receiving planned standard treatment of one or more of the following:
- •Chemotherapy regimens containing DTIC, TMZ and/or cisplatin
- •Immunotherapy (for example ipilimumab and/or anti-PD-L1/PD-1 therapies)
- •BRAF and/or MEK inhibitors
- •Patients were FFPE and fresh frozen tissue is available (both mandatory).
排除标准
- 未提供
结局指标
主要结局
Validation of SYS-ACT
时间窗: 2 years
Validate the predictive capacity of SYS-ACT by assessing responsiveness to treatment
Progression free survival
时间窗: 2 years
Progression free survival (PFS) and overall survival will be assessed for each patient for up to 2 years.
次要结局
未报告次要终点