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

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ClinicalTrials.gov Identifier: NCT04122937
Recruitment Status : Completed
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Anna Solini, University of Pisa

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.

Condition or disease Intervention/treatment
Peritoneal Carcinomatosis Ovarian Cancer Colon Cancer Procedure: Cytoreductive surgery

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : March 30, 2019


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 Name: 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 Name: Debulking




Primary Outcome Measures :
  1. Immune biomarkers [ Time Frame: Each patients will be assessed at baseline ]
    Serum levels of CD4, CD8, CUZD1, LAG3, PD1, PDL1, IMP1 e p62/IMP2 will be determine using ELISA.

  2. Metastatic mediators [ Time Frame: Each patients will be assessed at baseline ]
    Peritoneal expression of IL6, IL2, TNFα, TGFβ1, VEGF, CD68, FGFR1, CCL2/MCP-1, CD73 will be determine 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


Biospecimen Retention:   Samples With DNA
peritoneal biopsy


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122937


Locations
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Italy
University of Pisa
Pisa, Italy, 56125
Sponsors and Collaborators
University of Pisa
Investigators
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Principal Investigator: Anna Solini, MD, PhD University of Pisa

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Responsible Party: Anna Solini, Associate Professor, University of Pisa
ClinicalTrials.gov Identifier: NCT04122937     History of Changes
Other Study ID Numbers: AS0003
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anna Solini, University of Pisa:
peritoneal carcinomatosis
colon cancer
ovarian cancer
P2X7R-inflammasome
Additional relevant MeSH terms:
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Ovarian Neoplasms
Colonic Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Diseases
Abdominal Neoplasms
Carcinoma
Inflammation
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Peritoneal Diseases