Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer (MicroPCI)
Primary Purpose
Epithelial Ovarian Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Peritoneal biopsies after complete macroscopic cytoreduction
Sponsored by
About this trial
This is an interventional basic science trial for Epithelial Ovarian Cancer focused on measuring ovarian, peritoneal, recurrences, surgery, cancer, metastases
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years-old, French nationality
- with epithelial ovarian or tubal cancer
- Complete macroscopic cytoreductive surgery (CC-0) regardless of the sequence compared to chemotherapy.
- Patient giving express consent
Exclusion Criteria:
- Borderline ovarian tumor
- Incomplete cytoreductive surgery
- Pregnant women
- Major under guardianship / trusteeship,
- Not insured
Sites / Locations
- Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peritoneal biopsies
Arm Description
We will perform at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer random peritoneal biopsies in apparently healthy peritoneum in order to assess the presence of microscopic peritoneal metastases
Outcomes
Primary Outcome Measures
Identification of microscopic peritoneal metastases on pathological examination of peritoneal biopsies after complete macroscopic cytoreductive surgery for epithelial ovarian cancer.
Random peritoneal biopsies in apparently healthy peritoneum, will be performed at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer. If peritoneal metastases are identified on this sample, they will be the subject of a detailed morphological description.
Presence of microscopic peritoneal metastases will be measured (µm) using light microscope on HE slides from formalin fixed paraffin embedded tissues, by two different expert pathologists
Secondary Outcome Measures
Expression of folate receptor by microscopic peritoneal metastases and comparison with primary tumor
Expression of folate receptor will measured by immuno-histo-chemistry. The intensity of the expression will be evaluated using semiquantitative method.
Expression of folate receptor by microscopic peritoneal metastases will be assessed using immunohistochemistry with mouse monoclonal NCL-L-FRalpha antibody (Leica Biosystems). Expression will be quantified with a light microscope, using H-score according to the following formula : H-score = [1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)].
Full Information
NCT ID
NCT03754569
First Posted
July 16, 2018
Last Updated
October 18, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03754569
Brief Title
Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer
Acronym
MicroPCI
Official Title
Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 10, 2019 (Actual)
Study Completion Date
July 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the cytoreductive surgery carried out for the management of ovarian cancers is to obtain a complete macroscopic cytoreduction. This means that all visible peritoneal metastases must be resected. The peritoneum is the most frequent site of recurrence after initial management. There is no data on the existence, prevalence of microscopic peritoneal metastases. It nevertheless represents a therapeutic target (intraperitoneal chemotherapy). The main objective is the demonstration of microscopic peritoneal metastases in macroscopically healthy peritoneum after complete macroscopic cytoreductive surgery.
Detailed Description
Understanding biology and progression mechanisms of peritoneal metastases (PM) of epithelial ovarian cancer (EOC) is a cornerstone in the knowledge and the comprehensive management of the disease, as PM will occur in the majority of patients. Indeed, the goal of cytoreductive surgery (CRS) in these patients is to completely remove all visible peritoneal invasion because the absence of residual disease after surgery is known to improve the prognosis.
Despite clinical remission after the completion of complete surgery and platinum-based chemotherapy, 60% of patient develop peritoneal recurrence. This suggests that microscopic lesions may be present that are not eradicated by surgery, not controlled by systemic chemotherapy and that may be one of the mechanisms leading to peritoneal recurrence. Peritoneal carcinomatosis is responsible for the greatest morbidity and mortality in women with EOC.
There are very few studies in the literature on microscopic peritoneal involvement in EOC, its detection and potential role in the progression of cancer. The peritoneum should be considered an organ in its own right and the surgeon must treat peritoneal metastases with the intent to cure. To follow the recommendations, this microscopic disease must be managed, because complete CRS is now a skill that can be mastered skill and its uses is a validated guideline. Moreover, "complete CRS" should be defined as "without macroscopic residual disease" thus highlighting the presence of microscopic disease.
The goal of this study is to add scientific evidence for the existence of Microscopic Peritoneal Metastases (mPM) and to justify the need for additional diagnostic and therapeutic approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
ovarian, peritoneal, recurrences, surgery, cancer, metastases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peritoneal biopsies
Arm Type
Experimental
Arm Description
We will perform at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer random peritoneal biopsies in apparently healthy peritoneum in order to assess the presence of microscopic peritoneal metastases
Intervention Type
Procedure
Intervention Name(s)
Peritoneal biopsies after complete macroscopic cytoreduction
Intervention Description
We will perform at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer random peritoneal biopsies in apparently healthy peritoneum in order to assess the presence of microscopic peritoneal metastases
Primary Outcome Measure Information:
Title
Identification of microscopic peritoneal metastases on pathological examination of peritoneal biopsies after complete macroscopic cytoreductive surgery for epithelial ovarian cancer.
Description
Random peritoneal biopsies in apparently healthy peritoneum, will be performed at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer. If peritoneal metastases are identified on this sample, they will be the subject of a detailed morphological description.
Presence of microscopic peritoneal metastases will be measured (µm) using light microscope on HE slides from formalin fixed paraffin embedded tissues, by two different expert pathologists
Time Frame
one year
Secondary Outcome Measure Information:
Title
Expression of folate receptor by microscopic peritoneal metastases and comparison with primary tumor
Description
Expression of folate receptor will measured by immuno-histo-chemistry. The intensity of the expression will be evaluated using semiquantitative method.
Expression of folate receptor by microscopic peritoneal metastases will be assessed using immunohistochemistry with mouse monoclonal NCL-L-FRalpha antibody (Leica Biosystems). Expression will be quantified with a light microscope, using H-score according to the following formula : H-score = [1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)].
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years-old, French nationality
with epithelial ovarian or tubal cancer
Complete macroscopic cytoreductive surgery (CC-0) regardless of the sequence compared to chemotherapy.
Patient giving express consent
Exclusion Criteria:
Borderline ovarian tumor
Incomplete cytoreductive surgery
Pregnant women
Major under guardianship / trusteeship,
Not insured
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri M AZAIS, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer
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