NCT03754569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

October 21, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

July 16, 2018

Last Update Submit

October 18, 2019

Conditions

Epithelial Ovarian Cancer

Keywords

ovarianperitonealrecurrencessurgerycancermetastases

Outcome Measures

Primary Outcomes (1)

  • 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

    one year

Secondary Outcomes (1)

  • Expression of folate receptor by microscopic peritoneal metastases and comparison with primary tumor

    one year

Study Arms (1)

Peritoneal biopsies

EXPERIMENTAL

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

Interventions

Peritoneal biopsies after complete macroscopic cytoreductionPROCEDURE

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

Peritoneal biopsies

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Borderline ovarian tumor
  • Incomplete cytoreductive surgery
  • Pregnant women
  • Major under guardianship / trusteeship,
  • Not insured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix

Paris, 75013, France

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialRecurrenceNeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic Processes

Study Officials

  • Henri M AZAIS, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

November 27, 2018

Study Start

June 1, 2018

Primary Completion

July 10, 2019

Study Completion

July 10, 2019

Last Updated

October 21, 2019

Record last verified: 2019-01

Locations

FR(1)