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

NCT ID: NCT04122937

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-03-30

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.

Conditions

Peritoneal Carcinomatosis; Ovarian Cancer; Colon Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ovarian cancer

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

Cytoreductive surgery

Intervention Type: PROCEDURE

Partial removal of peritoneal tissue involved by neoplastic invasion

Colon cancer

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).

Cytoreductive surgery

Intervention Type: PROCEDURE

Partial removal of peritoneal tissue involved by neoplastic invasion

Interventions

Cytoreductive surgery

Partial removal of peritoneal tissue involved by neoplastic invasion

Intervention Type: PROCEDURE

Other Intervention Names

Debulking

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Anna Solini

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Solini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

University of Pisa

Pisa, , Italy

Countries

Italy

Other Identifiers

AS0003

Identifier Type: -

Identifier Source: org_study_id