Glutamate Excitotoxicity in Brain Metastases From Lung, Breast and Melanoma Treated With Stereotactic Radiosurgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum markers determination in newly diagnosed BM (lung, breast and melanoma) patients, before SRS treatment.
研究概览
简要总结
Brain metastases (BM) represents a devastating clinical reality, carrying an estimated survival time of less than one year. Number of reasons, including complicated tumor biology and difficulties in modeling metastatic cancer in brain microenvironment, do hinder research on this topic. BM are indeed the most frequent neoplasm in the central nervous system (CNS) and is estimated that up to 14% of all newly diagnosed cancers will metastasize to the brain. A number of reasons, including complicated tumor biology and difficulties in modeling metastatic cancer in brain microenvironment, do hinder research on this topic. Present knowledge regarding alterations in Glutamate (Glu) homeostasis and BM is poor. This study aims at investigating Glu balance in BM patients and providing supporting evidence to the identification of new putative biomarkers to be used as potential therapeutic targets.
详细描述
Experimental procedure:
Serum levels of glutamic oxaloacetic transaminase (GOT1), glutamate Pyruvate Transaminase (GPT) and lactate dehydrogenase (LDH) levels and serum glutamate, aspartate and lactate levels of a total of 100 patients will be collected and divided in three different groups:
- A: BM group (n=50), patients affected by BM from lung, breast and melanoma, candidates to SRS
- B: Control group 1 (n=25), patients with the same primary controlled tumors without nor brain nor extracranial metastases
- C: Control group 2 (n=25), patients with benign intracranial lesions candidates to SRS treatment.
In A) and C) serum GOT1, GPT and LDH levels and serum glutamate, aspartate, lactate levels will be evaluated before and after SRS treatment (at 3, 6 and 9 months follow-up).
In B) serum biomarkers levels will be only collected at baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 未提供
排除标准
- •Acute or chronic liver disease
- •Severe anemia (Hb <8g/dl)
- •Pregnant or breastfeeding patient
- •Pediatric patients
- •Patients not able to express informed consent
结局指标
主要结局
Serum markers determination in newly diagnosed BM (lung, breast and melanoma) patients, before SRS treatment.
时间窗: Baseline (pre-SRS);
GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels. All measures in mg/dl.
Serum markers determination in newly diagnosed BM (lung, breast and melanoma) patients, after SRS treatment.
时间窗: Baseline (pre-SRS) and at 3, 6 and 9 months
GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels. All measures in mg/dl.
Serum markers determination in melanoma, lung or breast cancer patients without BM.
时间窗: Baseline
Comparison of serum GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels between BM and non-BM patients. All measures in mg/dl.
Serum markers determination in patients carrying benign intracranial lesions before and after SRS treatment.
时间窗: Baseline (pre-SRS) and at 3, 6 and 9 months
Comparison of serum GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels between BM and benign lesion patients. All measures in mg/dl.
次要结局
- Studying correlation of serum markers levels with MRI changes following SRS-GK(3, 6 and 9 months)
研究者
Pietro Mortini, MD, Prof.
Head of department
IRCCS San Raffaele