Defining Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.

Completed

• Conditions: Peritoneal Carcinomatosis; Ovarian Cancer; Colon Cancer
• Interventions: Procedure: Cytoreductive surgery

• Registration Number: NCT04122937
• Lead Sponsor: University of Pisa

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 Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-06-01
• Study Completion: 2019-03-30
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovarian cancer	Cytoreductive surgery	Patients affected by ovarian cancer will be stratified according to BRCA1 and BRCA2 mutational status.
Colon cancer	Cytoreductive surgery	Patients affected by colon cancer will be similarly stratified according to BRAF and KRAS mutational status and to the presence of low-grade or high-grade microsatellite instability (MSI).

Primary Outcome Measures

Name	Time	Method
Immune biomarkers level	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	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	Each patients will be assessed at baseline	Peritoneal expression of NLRP3-ASC will be determine using RT-PCR

Trial Locations

Locations (1)

University of Pisa; 🇮🇹 Pisa, Italy