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

Borderline Ovarian Tumors Clinical Trial

— OPTIBOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690440
• Other study ID #: IC 2017-09
• Secondary ID: N° : 2018-A00092
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Borderline Ovarian Tumors
• Ovarian Neoplasms

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Centre Jean PERRIN	Clermont-Ferrand
France	Centre Leon Berard	Lyon
France	Institut Paoli CALMETTES	Marseille
France	Goupe Hospitalier Diaconesses Croix Saint-Simon	Paris
France	Hôpital Européen Goerges POMPIDOU	Paris
France	Institut Curie, Paris	Paris
France	Centre Hospitalier Intercommunal Poissy - Saint-Germain	Poissy
France	Institut Curie - Saint-Cloud	Saint-Cloud
France	IUCT Oncopole - Institut Claudius Regaud	Toulouse
France	Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN	Vandoeuvre les Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Institut Curie	ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors	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)	December 2018
Secondary	Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics	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.	December 2018