Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France (Ovaire01)
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|ClinicalTrials.gov Identifier: NCT02981901|
Recruitment Status : Not yet recruiting
First Posted : December 5, 2016
Last Update Posted : December 6, 2016
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 or disease||Intervention/treatment|
|Ovarian Epithelial Cancer||Other: Patient with ovarian epithelial cancer|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||December 2017|
Patient with ovarian epithelial cancer
Ovarian epithelial cancer diagnosed in 2012
|Other: Patient with ovarian epithelial cancer|
- 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
- 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 ]
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
|Contact: Isabelle RAY-COQUARD, PU-PH||+33 4 78 78 email@example.com|
|Contact: Claire CHEMIN||+ 33 4 78 78 51 firstname.lastname@example.org|
|Calvados registry||Not yet recruiting|
|Contact: Anne-Valérie GUIZARD, MD +33 2 31 45 52 84 AV.GUIZARD@baclesse.unicancer.fr|
|Côte d'or registry||Not yet recruiting|
|Contact: Patrick ARVEUX, MD-PhD PArveux@cgfl.fr|
|Oveval||Not yet recruiting|
|Contact: Claire CHEMIN +33 4 78 78 51 41 email@example.com|
|Principal Investigator:||Isabelle RAY-COQUARD, PU-PH||Centre Leon Berard|