Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Immune biomarkers level
研究概览
简要总结
Inflammation plays an important role in the pathogenesis of peritoneal carcinosis. Patients with elevated levels of different inflammation cytokines show a worse prognosis at the time of diagnosis. In women, ovarian and colon cancer are the main causes of peritoneal carcinosis and a comparison of these two different types of peritoneal invasion have not been conducted yet. We found interesting studying the role of immune response, in particular tumour-associated antigens (TAA) that modulate the metastatic process. We will investigate also mitochondrial defects, such as mutations in mt-DNA, potentially involved in carcinogenesis.
详细描述
At the time of hospitalization all the patients will undergo a complete clinical evaluation with determination of biochemical parameters such as fasting blood glucose, blood count, hs-CRP, AST and ALT, uric acid, creatinine and BUN. An extra blood aliquot will be collected to assess the serum biomarkers under investigation.
During surgery two samples of peritoneal tissue macroscopically undamaged will be collected. On those samples will be executed separation of adipocytes cells, RNA and protein extraction for measuring of inflammatory and neoplastic biomarkers, determination of P2X7R-inflammasome activity and mitochondrial DNA analyse.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histological diagnosis of peritoneal carcinosis secondary to colon cancer or high-grade ovarian cancer
- •patients able to consent
排除标准
- •previous malignancies, except for patients with cutaneous basal cell carcinoma, Cervical Intraepithelial Neoplasia (CIN) or melanoma in situ
- •current chemotherapy or radiotherapy
- •current steroid therapy or immunotherapy
- •patients affected by systemic inflammatory disease and/or Inflammatory bowel disease (IBD)
结局指标
主要结局
Immune biomarkers level
时间窗: Each patients will be assessed at baseline
Serum level of different immune related biomarkers (such as CD4, CD8, CUZD1, LAG3, PD1, PDL1, IMP1 and p62/IMP2) will be determined using ELISA.
Metastatic mediators level
时间窗: Each patients will be assessed at baseline
Peritoneal expression of cytokines related to metastatic process (such as IL6, IL2, TNFα, TGFβ1, VEGF, CD68, FGFR1, CCL2/MCP-1, CD73) will be determined using real time-PCR.
P2X7R-inflammasome activity
时间窗: Each patients will be assessed at baseline
Peritoneal expression of NLRP3-ASC will be determine using RT-PCR
次要结局
未报告次要终点
研究者
Anna Solini
Associate Professor
University of Pisa