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

Institut Curie

Status: Completed

Conditions: Borderline Ovarian Tumors

Study type: Observational

Funder types: Other

Identifiers

NCT03690440

IC 2017-09

N° : 2018-A00092-53 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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).