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

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ClinicalTrials.gov Identifier: NCT03690440
Recruitment Status : Completed
First Posted : October 1, 2018
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
ARCAGY/ GINECO GROUP
Information provided by (Responsible Party):
Institut Curie

Study Description
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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.


Condition or disease
Borderline Ovarian Tumors

Study Design
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Study Type : Observational
Actual Enrollment : 176 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: OPTIBOT: Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor (BOT)
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Fertility-sparing surgery for patients with borderline ovarian tumor and fertility.
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690440


Locations
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France
Institut Bergonié
Bordeaux, France, 33076
Centre Jean PERRIN
Clermont-Ferrand, France, 63011
Centre Leon Berard
Lyon, France, 69373
Institut Paoli CALMETTES
Marseille, France, 13009
Institut Curie, Paris
Paris, France, 75005
Hôpital Européen Goerges POMPIDOU
Paris, France, 75015
Goupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France, 75020
Centre Hospitalier Intercommunal Poissy - Saint-Germain
Poissy, France, 78300
Institut Curie - Saint-Cloud
Saint-Cloud, France, 92210
IUCT Oncopole - Institut Claudius Regaud
Toulouse, France, 31400
Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN
Vandoeuvre les Nancy, France, 54500
Sponsors and Collaborators
Institut Curie
ARCAGY/ GINECO GROUP
Investigators
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Study Director: Delphine HEQUET, MD PhD Institut Curie
More Information
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03690440    
Other Study ID Numbers: IC 2017-09
N° : 2018-A00092-53 ( Other Identifier: ID-RCB )
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: March 2019
Keywords provided by Institut Curie:
Borderline Ovarian Tumor (BOT)
Fertility-sparing surgery
Gynecology
Oncology
Additional relevant MeSH terms:
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Ovarian Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders