Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary Objective
研究概览
简要总结
DEEPLY aims to improve sarcoma therapy by the development of an innovative nanophotonic delivery approach to be applied in the future as an integrated local therapy for patients with inoperable tumors or with oligometastases. The major aim of the project is the development of innovative nanocarriers loaded with chemotherapeutic agents, whose delivery will be improved by the use of an optic fiber (optoporation). After the synthesis, and characterization of NPs, a prototype will be produced and preclinically validated on patient-derived biological material. This wide comprehensive methodological approach will ensure the obtainment of robust data to be faster exploited toward clinical applications.
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
- 2 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients eligible for the study will be male or female, with an age ranging from 0- to 85 years, undergoing surgery or biopsy for STSs or BSs including osteosarcomas.
- •Included patients may have undergone or may be still in treatment with chemotherapy (also neo-adjuvant settings), targeted therapy, radiotherapy, or combination therapy.
- •IRST will enroll only adult patients (age > 18 years).
- •Signed informed consent from all subjects enrolled in the study. IOR patients will have to sign both the specific project Informed Consent and the IOR Biobank Informed consent.
排除标准
- •Patients not affected by STSs or BSs will be excluded from the study, as well as patients with multiple primary tumors.
结局指标
主要结局
Primary Objective
时间窗: 2 years
The primary aim of the study will be to determine on primary cells or explants the efficacy of the innovative nanotechnology formulations established in the project.
次要结局
- Secondary Objectives(2 years)