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Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer (MicroPCI)

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ClinicalTrials.gov Identifier: NCT03754569
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Procedure: Peritoneal biopsies after complete macroscopic cytoreduction Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2019


Arm Intervention/treatment
Experimental: Peritoneal biopsies
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
Procedure: Peritoneal biopsies after complete macroscopic cytoreduction
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 Measures :
  1. Identification of microscopic peritoneal metastases on pathological examination of peritoneal biopsies after complete macroscopic cytoreductive surgery for epithelial ovarian cancer. [ Time Frame: one year ]

    Random peritoneal biopsies in apparently healthy peritoneum, will be performed at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer, in order to assess the presence of microscopic peritoneal metastases. 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 assessed and measured (µm) using light microscope on HE slides from formalin fixed paraffin embedded tissues, by two different expert pathologists



Secondary Outcome Measures :
  1. Expression of folate receptor by microscopic peritoneal metastases and comparison with primary tumor [ Time Frame: one year ]

    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+)].




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT03754569


Contacts
Contact: Henri M AZAIS, MD PhD +33 6 30 99 22 44 henri.azais@aphp.fr

Locations
France
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix Recruiting
Paris, France, 75013
Contact: Henri M AZAIS, MD PhD    +33 6 30 99 22 44    henri.azais@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Henri M AZAIS, MD PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03754569     History of Changes
Other Study ID Numbers: K171203J
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ovarian
peritoneal
recurrences
surgery
cancer
metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Neoplasms
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type