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

Study Overview
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Brief Summary
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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.

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

Conditions
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Borderline Ovarian Tumors

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Borderline Ovarian Tumor (BOT), Fertility-sparing surgery, Gynecology, Oncology