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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04122937
Acronym
CarFlog
Enrollment
30
Registered
2019-10-10
Start date
2017-03-01
Completion date
2019-03-30
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Ovarian Cancer, Peritoneal Carcinomatosis

Keywords

peritoneal carcinomatosis, colon cancer, ovarian cancer, P2X7R-inflammasome

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.

Interventions

PROCEDURECytoreductive surgery

Partial removal of peritoneal tissue involved by neoplastic invasion

Sponsors

University of Pisa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Immune biomarkers levelEach patients will be assessed at baselineSerum 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 levelEach patients will be assessed at baselinePeritoneal 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 activityEach patients will be assessed at baselinePeritoneal expression of NLRP3-ASC will be determine using RT-PCR

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026