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

Ovarian Cancer Clinical Trial

— CarFlog  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122937
• Other study ID #: AS0003
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: November 2019
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Colon Cancer
• Colonic Neoplasms
• Inflammation
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Procedure:
• Cytoreductive surgery
Partial removal of peritoneal tissue involved by neoplastic invasion

Locations

Country	Name	City	State
Italy	University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune biomarkers level	Serum level of different immune related biomarkers (such as CD4, CD8, CUZD1, LAG3, PD1, PDL1, IMP1 and p62/IMP2) will be determined using ELISA.	Each patients will be assessed at baseline
Primary	Metastatic mediators level	Peritoneal expression of cytokines related to metastatic process (such as IL6, IL2, TNFa, TGFß1, VEGF, CD68, FGFR1, CCL2/MCP-1, CD73) will be determined using real time-PCR.	Each patients will be assessed at baseline
Primary	P2X7R-inflammasome activity	Peritoneal expression of NLRP3-ASC will be determine using RT-PCR	Each patients will be assessed at baseline