Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pisa
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Immune biomarkers level
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •histological diagnosis of peritoneal carcinosis secondary to colon cancer or high-grade ovarian cancer
- •patients able to consent
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Immune biomarkers level
Time Frame: 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
Time Frame: 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
Time Frame: Each patients will be assessed at baseline
Peritoneal expression of NLRP3-ASC will be determine using RT-PCR
Secondary Outcomes
No secondary outcomes reported
Investigators
Anna Solini
Associate Professor
University of Pisa