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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03690440

Acronym

OPTIBOT

Enrollment

176

Registered

2018-10-01

Start date

2018-06-15

Completion date

2018-12-31

Last updated

2019-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Ovarian Tumors

Keywords

Borderline Ovarian Tumor (BOT), Fertility-sparing surgery, Gynecology, Oncology

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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).

Design outcomes

Primary

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

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

Countries

France

Outcome results