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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-15

Study Completion Date

2018-12-31

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.

Detailed Description

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Conditions

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Borderline Ovarian Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ARCAGY/ GINECO GROUP

OTHER

Sponsor Role collaborator

Institut Curie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delphine HEQUET, MD PhD

Role: STUDY_DIRECTOR

Institut Curie

Locations

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Institut Bergonié

Bordeaux, , France

Site Status

Centre Jean PERRIN

Clermont-Ferrand, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

Institut Paoli CALMETTES

Marseille, , France

Site Status

Institut Curie, Paris

Paris, , France

Site Status

Hôpital Européen Goerges POMPIDOU

Paris, , France

Site Status

Goupe Hospitalier Diaconesses Croix Saint-Simon

Paris, , France

Site Status

Centre Hospitalier Intercommunal Poissy - Saint-Germain

Poissy, , France

Site Status

Institut Curie - Saint-Cloud

Saint-Cloud, , France

Site Status

IUCT Oncopole - Institut Claudius Regaud

Toulouse, , France

Site Status

Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

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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