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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Borderline Ovarian Tumors Neoplasms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Institut Bergonié, Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors

Time frame: December 2018

Univariate and multivariate analysis on patients modalities of care and fertility , through medical history and questionnaires (study based on patients who were included in the previous study "Observatoire Sur Les Tumeurs Malignes Rares de l'Ovaire" (TMRO french network)

Secondary outcomes

Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics

Time frame: December 2018

Test of a published fertility prognostic tool in this population. Estimation of the precision of the estimation of alive birth in our cohort will be done by determining the difference between predicted live birth and observed rate of live birth.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Collaborators

ARCAGY/ GINECO GROUP

Registry information

Official study title

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

Acronym: OPTIBOT

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Oct 1, 2018
Registry last updated: Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed