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

Completed
Conditions
Borderline Ovarian Tumors
Registration Number
NCT03690440
Lead Sponsor
Institut Curie
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
176
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.
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Exclusion Criteria
  • The patients who are not corresponding to the selection criteria are straightaway excluded from the retrospective database selected for the study (TMRO).
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumorsDecember 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)

Secondary Outcome Measures
NameTimeMethod
Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristicsDecember 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.

Trial Locations

Locations (11)

Centre Jean PERRIN

🇫🇷

Clermont-Ferrand, France

Institut Bergonié

🇫🇷

Bordeaux, France

Centre Leon Berard

🇫🇷

Lyon, France

Institut Curie, Paris

🇫🇷

Paris, France

Institut Paoli CALMETTES

🇫🇷

Marseille, France

Hôpital Européen Goerges POMPIDOU

🇫🇷

Paris, France

Goupe Hospitalier Diaconesses Croix Saint-Simon

🇫🇷

Paris, France

Centre Hospitalier Intercommunal Poissy - Saint-Germain

🇫🇷

Poissy, France

IUCT Oncopole - Institut Claudius Regaud

🇫🇷

Toulouse, France

Institut Curie - Saint-Cloud

🇫🇷

Saint-Cloud, France

Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN

🇫🇷

Vandoeuvre les Nancy, France

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