Predicting Response Patterns to Treatment in Glioblastoma (GBM) Oncology Patients Based on Host Response Evaluation During Anti-cancer Treatments
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Response to treatment
研究概览
简要总结
PROPHETIC GBM - Predicting response patterns to treatment in Glioblastoma (GBM) oncology patients based on host response evaluation during anti-cancer treatments
详细描述
The goal of this research study is identify new host response proteins, pathways and mechanisms that are associated with responsiveness to GBM treatment modalities.
This will serve as a tool for physicians when making treatment decisions. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide up to 5 blood samples and clinical data will be collected from their medical records.
The data obtained from the blood samples and the medical records of the patients will be used to search for potential mechanisms that are involved in response to treatment, and to identify potential targets to increase the response, and hence, increase treatment effectiveness or suggest potential new treatments.
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
- •Provision of informed consent prior to any study-specific procedures.
- •Male or female aged at least 18 years.
- •KPS not less than
- •Normal hematologic, renal and liver function:
- •Absolute neutrophil count above 1500/mm3, platelets above 100,000/mm3, hemoglobin above 9 g/dL;
- •Creatinine concentration not more than 1.4 mg/dL, or creatinine clearance above 40 mL/min;
- •Total bilirubin below 1.5 mg/dL, ALT+ AST levels not more than 3 times above the upper normal limit.
- •Patients planned to receive standard of care TMZ+RT treatment; TTF therapy during RT is permitted.
排除标准
- •Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of surgery. Except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to screening, and carcinoma in situ of the cervix that have been completely excised and cured at least 5 years prior to screening.
- •Participation in another clinical trial which includes an investigational drug.
- •Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
结局指标
主要结局
Response to treatment
时间窗: 36 months after treatment completion in the first year
CR, PR, SD, PD, suspected pseudo-progression, as defined by RANO
Blood levels of proteins
时间窗: If the previous detection of progression turned out to be pseudo-progression, then an additional blood sample should be drawn at time of progression, assessed up to 36 months
Changes in Blood levels of proteins representing the Host response compared to baseline
次要结局
- OS(Until death or 3 years)
- PFS(up to 3 years)