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

November 21, 2019 updated by: Anna Solini, University of Pisa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56125
        • University of Pisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study consecutively enrolled 30 patients undergoing surgical treatment for peritoneal carcinosis: 15 patients affected by high grade ovarian cancer and 15 patients affected by colon cancer. Patients will be enrolled among those referring to the Gynaecologic Unit and the General Surgery Unit, University Hospital of Pisa, Italy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune biomarkers level
Time Frame: 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.
Each patients will be assessed at baseline
Metastatic mediators level
Time Frame: 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.
Each patients will be assessed at baseline
P2X7R-inflammasome activity
Time Frame: Each patients will be assessed at baseline
Peritoneal expression of NLRP3-ASC will be determine using RT-PCR
Each patients will be assessed at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

March 30, 2019

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (ACTUAL)

October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS0003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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