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

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: Borderline Ovarian Tumors

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonie
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Lyon, France, 69373
    • Centre Léon Bérard
  • 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 Régaud
  • Vandoeuvre les Nancy, France, 54500
    • Institut de Cancérologie de Lorraine - Centre Alexis Vautrin

Participation Criteria

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

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	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	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

• Sponsor: Institut Curie
• Collaborators: ARCAGY/ GINECO GROUP
• Investigators: Study Director: Delphine HEQUET, MD PhD, Institut Curie

Study record dates

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: Oncology; Gynecology; Borderline Ovarian Tumor (BOT); Fertility-sparing surgery
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: IC 2017-09; N° : 2018-A00092-53 (Other Identifier: ID-RCB)