NCT03690440

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 176 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Borderline Ovarian Tumors

Timeline

• Start date: 2018-06-15
• Primary completion: 2018-09-30
• Completion: 2018-12-31
• First posted: 2018-10-01
• Last updated: 2019-10-30

Locations

11 sites across 1 country: France