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

University of Pisa

Status: Completed

Conditions: Colon Cancer; Ovarian Cancer; Peritoneal Carcinomatosis

Treatments: Procedure: Cytoreductive surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04122937

AS0003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 2 patient groups

Ovarian cancer

Description:

Patients affected by ovarian cancer will be stratified according to BRCA1 and BRCA2 mutational status.

Treatment:

Procedure: Cytoreductive surgery

Colon cancer

Description:

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).

Treatment:

Procedure: Cytoreductive surgery