Peritoneal CarcinomatosisCarFlogNCT04122937
Defining Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
An observational study of Peritoneal Carcinomatosis and Ovarian Cancer, run by University of Pisa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Peritoneal Carcinomatosis, Ovarian Cancer, Colon Cancer
- What is being tested?
- Cytoreductive surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2017to 30 Mar 2019
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- histological diagnosis of peritoneal carcinosis secondary to colon cancer or high-grade ovarian cancer
- patients able to consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Characterisation and Clinical Implications of 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.
Read the 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.
- Conditions
- Peritoneal Carcinomatosis, Ovarian Cancer, Colon Cancer
- Being tested
- Cytoreductive surgery
- Keywords
- peritoneal carcinomatosis, colon cancer, ovarian cancer, P2X7R-inflammasome
- Medical subject headings
- Peritoneal Neoplasms, Ovarian Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgeryProcedure or surgery
Also called Debulking
Partial removal of peritoneal tissue involved by neoplastic invasion
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer | Patients affected by ovarian cancer will be stratified according to BRCA1 and BRCA2 mutational status. Receives: Procedure: Cytoreductive surgery | |
| 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). Receives: Procedure: Cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune biomarkers level
Serum level of different immune related biomarkers (such as CD4, CD8, CUZD1, LAG3, PD1, PDL1, IMP1 and p62/IMP2) will be determined using ELISA.
Measured: Each patients will be assessed at baseline
Metastatic mediators level
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.
Measured: Each patients will be assessed at baseline
P2X7R-inflammasome activity
Peritoneal expression of NLRP3-ASC will be determine using RT-PCR
Measured: Each patients will be assessed at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Mar 2017
- Primary completion1 Jun 2018
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Solini, University of Pisa
- Investigators
- Anna Solini, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122937
- Sponsor's protocol ID
- AS0003
- Acronym
- CarFlog
- Status last verified
- Nov 2019
- First submitted
- 9 Oct 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterisation and Clinical Implications of Inflammation Related to Peritoneal Carcinomatosis in Women With Ovarian or Colon Cancer.
- ClinicalTrials.gov ID
- NCT04122937
- Acronym / sponsor ID
- CarFlog / AS0003
- Conditions
- Peritoneal Carcinomatosis, Ovarian Cancer, Colon Cancer
- Keywords
- peritoneal carcinomatosis, colon cancer, ovarian cancer, P2X7R-inflammasome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer | – | Procedure: Cytoreductive surgeryPatients affected by ovarian cancer will be stratified according to BRCA1 and BRCA2 mutational status. |
| Colon cancer | – | Procedure: Cytoreductive surgeryPatients 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). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- histological diagnosis of peritoneal carcinosis secondary to colon cancer or high-grade ovarian cancer
- patients able to consent
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytoreductive surgeryAlso: DebulkingPartial removal of peritoneal tissue involved by neoplastic invasion | Procedure or surgery | Colon cancer, Ovarian cancer |
Primary outcome
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.
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.
P2X7R-inflammasome activity
Time frame: Each patients will be assessed at baseline
Peritoneal expression of NLRP3-ASC will be determine using RT-PCR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
Related trials for Peritoneal Carcinomatosis
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 1
Intraperitoneal Paclitaxel With NALIRIFOX for Pancreatic Ductal Adenocarcinoma With Peritoneal Carcinomatosis
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 2
Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis
Synchronous Gastric Peritoneal Carcinomatosis, Gastroesophageal Peritoneal Carcinomatosis
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
RecruitingPhase 1
A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer or Malignant Peritoneal Mesothelioma
Mesothelin Positive, Mesothelin-Expressing Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Solini, MD, PhD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Carcinomatosis and Ovarian Cancer, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune biomarkers level (time frame: Each patients will be assessed at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.