Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (OPTIBOT)

October 29, 2019 updated by: Institut Curie

OPTIBOT: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (BOT)

Retrospective and prospective multi-center study

Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility

Objectives:

  • Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors, the modalities of care and their fertility.
  • Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics

Origin and nature of the specific data:

  • Extraction from the database " Tumeurs Malignes Rares de l'Ovaire " (TMRO)
  • Collection of retrospective further informations in the participating centers
  • Data collection from the patients (questionnaires) The data will be identified by the TMRO number allocated to every participant of the TMRO study .

Data traffic :

TMRO database extraction for the patients with BOT and corresponding to the inclusion criteria, supplied by Arcagy-Gineco.

The database will be managed by the coordination team in an anonymous way by means of the patient identifiers of the TMRO base.

Enrichment of the base by the anonymous questionnaires filled by the patients and the complementary data transmissions of the centers on anonymised files.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Paris, France, 75005
        • Institut Curie, Paris
      • Paris, France, 75015
        • Hôpital Européen Goerges POMPIDOU
      • Paris, France, 75020
        • Goupe Hospitalier Diaconesses Croix Saint-Simon
      • Poissy, France, 78300
        • Centre Hospitalier Intercommunal Poissy - Saint-Germain
      • Saint-Cloud, France, 92210
        • Institut Curie - Saint-Cloud
      • Toulouse, France, 31400
        • IUCT Oncopole - Institut Claudius Regaud
      • Vandoeuvre les Nancy, France, 54500
        • Institut de Cancérologie de Lorraine - Centre Alexis Vautrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Fertility-sparing surgery for patients with borderline ovarian tumor and fertility.

Description

Inclusion Criteria:

  • Women with history of Borderline Ovarian Tumor (BOT).
  • Women who have had first a fertility-sparing surgery.
  • Women old enough to procreate (= 45 years) during their first surgery.
  • Women having agreed to participate in the previous study "Observatoire sur les Tumeurs Malignes Rares de l'Ovaire" (TMRO).
  • Women who have not expressed their opposition to the research.

Exclusion Criteria:

  • The patients who are not corresponding to the selection criteria are straightaway excluded from the retrospective database selected for the study (TMRO).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors
Time Frame: December 2018
Univariate and multivariate analysis on patients modalities of care and fertility , through medical history and questionnaires (study based on patients who were included in the previous study "Observatoire Sur Les Tumeurs Malignes Rares de l'Ovaire" (TMRO french network)
December 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics
Time Frame: December 2018
Test of a published fertility prognostic tool in this population. Estimation of the precision of the estimation of alive birth in our cohort will be done by determining the difference between predicted live birth and observed rate of live birth.
December 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Collaborators

ARCAGY/ GINECO GROUP

Investigators

  • Study Director: Delphine HEQUET, MD PhD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 4, 2018

First Submitted That Met QC Criteria

September 27, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC 2017-09
  • N° : 2018-A00092-53 (Other Identifier: ID-RCB)

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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