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Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France (Ovaire01)

This study is not yet open for participant recruitment.
Verified November 2016 by Centre Leon Berard
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981901
First Posted: December 5, 2016
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Cancer Côte d'or registry
Cancer Calvados registry
Information provided by (Responsible Party):
Centre Leon Berard
  Purpose

No structured organization for ovarian first line management emerges in France. Management across France seems to depend on regional contexts.

Regions display no specific organization or delineate regional network for the ovarian cancer management or report centralized management revolving around referent centers. These different templates present a major problem in identifying differences, costs and benefit.

To deal with this issue the Investigators propose a health economic evaluation based on cost-effectiveness analyses, completed with a budget impact analysis. This study will investigate the cost-effective management of patients with initial ovarian cancer using databases representative of different parts of French territories.


Condition Intervention
Ovarian Epithelial Cancer Other: Patient with ovarian epithelial cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained [ Time Frame: 2 years after diagnosis ]
    To perform a cost-effectiveness analysis in order to evaluate the most efficient organization for ovarian cancer in 1st line ot treatment


Secondary Outcome Measures:
  • Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained. [ Time Frame: 2 years after diagnosis ]
  • Budget impact analysis [ Time Frame: 2 years after diagnosis ]

    Cost assessment performed retrospectively for each patient: hospital stays, visits and other health-related costs will be identified and measured based on the French national Health Insurance perspective.

    QALY (Quality-Adjusted Life Year)


  • Relapse-free survival (RFS) [ Time Frame: RFS will be assessed 2 years after diagnosis ]

Estimated Enrollment: 400
Study Start Date: January 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient with ovarian epithelial cancer
Ovarian epithelial cancer diagnosed in 2012
Other: Patient with ovarian epithelial cancer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with ovarian epithelial cancer diagnosed in 2012
Criteria

Inclusion Criteria:

  • Ovarian epithelial cancer initially diagnosed in 2012
  • Age > 18 years old
  • Residency in France (Rhône-Alpes region, District of Calvados and Cotes d'Or)
  • First-line ovarian epithelial cancer

Exclusion Criteria:

  • Relapsed ovarian epithelial cancer
  • Non epithelial ovarian cancer
  Contacts and Locations
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): NCT02981901


Contacts
Contact: Isabelle RAY-COQUARD, PU-PH +33 4 78 78 5145 isabelle.ray-coquard@lyon.unicancer.fr
Contact: Claire CHEMIN + 33 4 78 78 51 41 claire.chemin@lyon.unicancer.fr

Locations
France
Calvados registry Not yet recruiting
Caen, France
Contact: Anne-Valérie GUIZARD, MD    +33 2 31 45 52 84    AV.GUIZARD@baclesse.unicancer.fr   
Côte d'or registry Not yet recruiting
Dijon, France
Contact: Patrick ARVEUX, MD-PhD       PArveux@cgfl.fr   
Oveval Not yet recruiting
Lyon, France
Contact: Claire CHEMIN    +33 4 78 78 51 41    claire.chemin@lyon.unicancer.fr   
Sponsors and Collaborators
Centre Leon Berard
Cancer Côte d'or registry
Cancer Calvados registry
Investigators
Principal Investigator: Isabelle RAY-COQUARD, PU-PH Centre Leon Berard
  More Information

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02981901     History of Changes
Other Study ID Numbers: Ovaire01
First Submitted: November 28, 2016
First Posted: December 5, 2016
Last Update Posted: December 6, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type