- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04122937
Defining Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer. (CarFlog)
Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Pisa, Italy, 56125
- University of Pisa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
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Partial removal of peritoneal tissue involved by neoplastic invasion
Other Names:
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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).
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Partial removal of peritoneal tissue involved by neoplastic invasion
Other Names:
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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
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Serum level of different immune related biomarkers (such as CD4, CD8, CUZD1, LAG3, PD1, PDL1, IMP1 and p62/IMP2) will be determined using ELISA.
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Each patients will be assessed at baseline
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Metastatic mediators level
Time Frame: Each patients will be assessed at baseline
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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.
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Each patients will be assessed at baseline
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P2X7R-inflammasome activity
Time Frame: Each patients will be assessed at baseline
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Peritoneal expression of NLRP3-ASC will be determine using RT-PCR
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Each patients will be assessed at baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Abdominal Neoplasms
- Colorectal Neoplasms
- Carcinoma
- Inflammation
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Colonic Neoplasms
Other Study ID Numbers
- AS0003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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