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Completed

NCT Number: NCT04122937

Defining 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.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Adnexal Diseases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Peritoneal Diseases Peritoneal Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

25 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Pisa

Pisa, 56125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

cytoreductive surgery

Procedure

Partial removal of peritoneal tissue involved by neoplastic invasion

Other names: Debulking

Primary outcomes

  1. 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.

  2. 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.

  3. P2X7R-inflammasome activity

    Time frame: Each patients will be assessed at baseline

    Peritoneal expression of NLRP3-ASC will be determine using RT-PCR

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: CarFlog

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 10, 2019
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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