Clinical trial NCT03690440: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor
Official title: OPTIBOT: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (BOT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Borderline Ovarian Tumors
Keywords: Borderline Ovarian Tumor (BOT)
Fertility-sparing surgery
Gynecology
Oncology
Lead sponsor: Institut Curie
Sponsor class: OTHER
Collaborators: name: ARCAGY/ GINECO GROUP
First posted: 2018-10-01
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors
timeFrame: December 2018
Secondary outcomes:
measure: Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics
timeFrame: December 2018
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Institut Paoli CALMETTES
city: Paris
country: France
facility: Institut Curie, Paris
city: Paris
country: France
facility: Hôpital Européen Goerges POMPIDOU
city: Paris
country: France
facility: Goupe Hospitalier Diaconesses Croix Saint-Simon
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal Poissy - Saint-Germain
city: Saint-Cloud
country: France
facility: Institut Curie - Saint-Cloud
city: Toulouse
country: France
facility: IUCT Oncopole - Institut Claudius Regaud
city: Vandoeuvre les Nancy
country: France
facility: Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN
Study officials:
affiliation: Institut Curie
name: Delphine HEQUET, MD PhD
role: STUDY_DIRECTOR
References: