Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor
NCT ID: NCT03690440
Last Updated: 2019-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
176 participants
OBSERVATIONAL
2018-06-15
2018-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Delphine HEQUET, MD PhD
Role: STUDY_DIRECTOR
Institut Curie
Locations
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Institut Bergonié
Bordeaux, , France
Centre Jean PERRIN
Clermont-Ferrand, , France
Centre Leon Berard
Lyon, , France
Institut Paoli CALMETTES
Marseille, , France
Institut Curie, Paris
Paris, , France
Hôpital Européen Goerges POMPIDOU
Paris, , France
Goupe Hospitalier Diaconesses Croix Saint-Simon
Paris, , France
Centre Hospitalier Intercommunal Poissy - Saint-Germain
Poissy, , France
Institut Curie - Saint-Cloud
Saint-Cloud, , France
IUCT Oncopole - Institut Claudius Regaud
Toulouse, , France
Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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N° : 2018-A00092-53
Identifier Type: OTHER
Identifier Source: secondary_id
IC 2017-09
Identifier Type: -
Identifier Source: org_study_id
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