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

Sponsor

University of Pisa (Other)

Overall Status

Completed

CT.gov ID

NCT04122937

Collaborator

(none)

Enrollment

Location

24.9

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Carcinomatosis Ovarian Cancer Colon Cancer	Procedure: Cytoreductive surgery

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 [Patient Registry]

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Mar 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Ovarian cancer Patients affected by ovarian cancer will be stratified according to BRCA1 and BRCA2 mutational status.	Procedure: Cytoreductive surgery Partial removal of peritoneal tissue involved by neoplastic invasion Other Names: Debulking
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).	Procedure: Cytoreductive surgery Partial removal of peritoneal tissue involved by neoplastic invasion Other Names: Debulking

Arm

Intervention/Treatment

Ovarian cancer

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

Procedure: Cytoreductive surgery

Partial removal of peritoneal tissue involved by neoplastic invasion

Other Names:

Debulking

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).

Procedure: Cytoreductive surgery

Partial removal of peritoneal tissue involved by neoplastic invasion

Other Names:

Debulking

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts 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)