Clinical Trial: Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France

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.


Detailed Summary:
Sponsor: Centre Leon Berard

Current Primary Outcome: 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


Original Primary Outcome: 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 tretament


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Incremental cost-effectiveness ratio expressed in cost per QALY gained [ Time Frame: 2 years after diagnosis ]
  • Cost assessment performed retrospectively for each patient [ Time Frame: 2 years after diagnosis ]
    Hospital stays, visits and other health-related costs will be indentified and measured based on the French national Health Insurance perspective
  • Relapse-free survival (RFS) [ Time Frame: RFS will be assessed 2 years after diagnosis ]


Information By: Centre Leon Berard

Dates:
Date Received: November 28, 2016
Date Started: January 2017
Date Completion: December 2017
Last Updated: December 5, 2016
Last Verified: November 2016