Clinical trial NCT04122937: Defining Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
Official title: Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Carcinomatosis
Ovarian Cancer
Colon Cancer
Keywords: peritoneal carcinomatosis
colon cancer
ovarian cancer
P2X7R-inflammasome
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Immune biomarkers level
timeFrame: Each patients will be assessed at baseline
measure: Metastatic mediators level
timeFrame: Each patients will be assessed at baseline
measure: P2X7R-inflammasome activity
timeFrame: Each patients will be assessed at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
affiliation: University of Pisa
name: Anna Solini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: