NCT03690440

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 30, 2019

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

July 4, 2018

Last Update Submit

October 29, 2019

Conditions

Borderline Ovarian Tumors

Keywords

Borderline Ovarian Tumor (BOT)Fertility-sparing surgeryGynecologyOncology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Fertility-sparing surgery for patients with borderline ovarian tumor and fertility.

You may qualify if:

  • 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.

You may not qualify if:

  • The patients who are not corresponding to the selection criteria are straightaway excluded from the retrospective database selected for the study (TMRO).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Jean PERRIN

Clermont-Ferrand, 63011, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Paoli CALMETTES

Marseille, 13009, France

Location

Institut Curie, Paris

Paris, 75005, France

Location

Hôpital Européen Goerges POMPIDOU

Paris, 75015, France

Location

Goupe Hospitalier Diaconesses Croix Saint-Simon

Paris, 75020, France

Location

Centre Hospitalier Intercommunal Poissy - Saint-Germain

Poissy, 78300, France

Location

Institut Curie - Saint-Cloud

Saint-Cloud, 92210, France

Location

IUCT Oncopole - Institut Claudius Regaud

Toulouse, 31400, France

Location

Institut de Cancérologie de Lorraine - Centre Alexis VAUTRIN

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Delphine HEQUET, MD PhD

    Institut Curie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2018

First Posted

October 1, 2018

Study Start

June 15, 2018

Primary Completion

September 30, 2018

Study Completion

December 31, 2018

Last Updated

October 30, 2019

Record last verified: 2019-03

Locations

FR(11)