Ovaire01: Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France
Study Details
Study Description
Brief Summary
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patient with ovarian epithelial cancer Ovarian epithelial cancer diagnosed in 2012 |
Other: Patient with ovarian epithelial cancer
|
Outcome Measures
Primary Outcome Measures
- Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained [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. [2 years after diagnosis]
- Budget impact analysis [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) [RFS will be assessed 2 years after diagnosis]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Calvados registry | Caen | France | ||
| 2 | Côte d'or registry | Dijon | France | ||
| 3 | Oveval | Lyon | France |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Ovaire01