Biomolecular Markers of Bone Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Bone metastasis profiling
研究概览
简要总结
The goal of this clinical trial is to characterize the biomolecular profile of bone metastases to define the predisposing profiles of bone metastasis, in patients with breast or lung or renal carcinomas or of the gastroenteric or prostate tract with bone metastasis.
The main question it aims to answer is:
Is it possible to predict the progression of bone metastasis by identifying biomarkers as risk factors for bone metastasis?
详细描述
Metastasization is a process that involves molecular change: potentially colonizable healthy tissues, particularly bone marrow, may "respond" to the production of factors released by the primary tumor, changing some of their funcional molecular characteristics in order to facilitate colonization by circulating tumor cells.
This study aims to describe the biomolecular profile of bone metastases. For this purpose, as per normal clinical practice, patients with carcinomas and who have developed bone metastases will undergo sampling of the metastases and primary tumors.
The activities will have multidisciplinary management. The study will include patients with carcinoma with bone metastases for whom the collection of biological material from the primary lesion and/or bone metastasis is an integral part of the diagnostic-therapeutic procedure or patients for whom, by clinical practice, a biopsy collection is performed because:
- histologic evaluation of the primary or metastatic lesion has been requested;
- a pathologic fracture to be treated surgically occurs;
- prophylactic orthopedic stabilization is required.
These samples will later be analyzed from a molecular point of view in order to identify a biomolecular profile that can help in defining profiles predisposing to bone metastasis and profiles predisposing to pathological fracture risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age >= 18 years
- •Patients with breast or lung or renal or gastroenteric tract or prostate with bone metastases
- •Patients who knowingly express willingness to participate in the study after signing the written informed consent
排除标准
- 未提供
结局指标
主要结局
Bone metastasis profiling
时间窗: up to 100 weeks
Characterizing the biomolecular profile of bone metastasis to define the predisposing profiles of bone metastasis. Transcriptional profile of * RANK/RANKL * OPG * PTHLH * IL-1/6/7/8/11, * TNF-alfa
Fracture pathological profiling
时间窗: up to 100 weeks
Characterizing the biomolecular profile of bone metastasis to define the predisposing risk profiles of fracture pathological. Fracture event yes/no and association with primary outcomes.
次要结局
- Comparison between the biomolecular profile of the mestastases and the primary tumor(up to 100 weeks)
- Comparison between the biomolecular profiles of osteolytic and osteosclerotic metastases(up to 100 weeks)
- Measuring PTH-rp (parathormone-related peptide) levels and the risk of pathologic facture(Every 3-6 months)