New Preclinical and Clinical Approaches to Mesothelioma, an Archetypal Inflammatory Tumor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- To set up spheroids models and serve as a platform
研究概览
简要总结
This study protocol involves the coordination between UO1 (IRCCS San Raffaele Hospital) and UO2 (Istituto Nazionale Tumori di Napoli - IRCCS G. Pascale) to explore the role of HMGB1 and CXCR4 in cancer treatment and metastasis. UO1 focuses on the role of HMGB1 in inflammation, mesothelioma progression, and tissue repair, as well as developing, in future, possible HMGB1 inhibitors for cancer therapy. UO2 specializes in CXCR4's role in cancer, developing CXCR4 antagonists, and tracking CXCR4-dependent metastasis. The hypothesis is that targeting HMGB1 and CXCR4 pathways will inhibit tumor progression and metastasis, enhancing anti-tumor immunity and improving therapeutic outcomes in cancer.
详细描述
This is a multicentric cross-sectional observational study with an additional blood volume collected during blood sampling performed for normal clinical practice. The enrollment will take
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Mesothelioma:
- •Clinical suspicion or histologically confirmed diagnosis of pleural mesothelioma.
- •Candidates for surgical intervention.
- •Age 18 years or older. It is possible to include both male and female patients, male and female patients of reproductive age, as well as breastfeeding women.
- •Capacity to comprehend the study nature and provide autonomously informed consent.
- •Control Group patients:
- •Absence of pleural mesothelioma but presence of other histologically confirmed diseases (neoplastic, inflammatory, or infectious).
- •Candidates for surgical intervention.
- •Age 18 years or older. It is possible to include both male and female patients, male and female patients of reproductive age, as well breastfeeding women.
- •Ability to understand the study nature and provide autonomously informed consent.
- •If the patient's diagnosis, whether provisional or definitive, does not confirm the clinical suspicion, they will not undergo further evaluation in the study.
排除标准
- •Lack of biopsy material.
- •pregnancy.
- •Unwillingness to sign the Informed Consent.
结局指标
主要结局
To set up spheroids models and serve as a platform
时间窗: 0/baseline
Evaluation of macrophages polarization status M1 or M2 based on different genes and proteins expression using qPCR and Flow Cytometry.
Test inhibitors on spheroids and organoids and assess the response of individual patients to therapy
时间窗: 0/baseline
Rate of growth to test the efficacy of anti-CSF1R, BoxA and DFL using human mesospheres from MPM primary cell lines derived from patients and monocytes from controls.
To set up spheroids models to study and serve as a platform
时间窗: 0/baseline
Number of spheroids with infiltrated macrophages. About of 30% of macrophages infiltrated into spheroids.
To set up organoid models
时间窗: 0/baseline
Number of organoids formation. About of 30% of biopsies generated organoids.
次要结局
- To investigate inhibitors of the CXCR4-CXCL12-HMGB1 axis on the crosstalk(In vivo experiment 3 weeks.)
研究者
Marco Emilio Bianchi
Professor
IRCCS Ospedale San Raffaele