Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France

• Conditions: Ovarian Epithelial Cancer
• Interventions: Other: Patient with ovarian epithelial cancer

• Registration Number: NCT02981901
• Lead Sponsor: Centre Leon Berard

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-05
• Study Start: 2017-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 376

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with ovarian epithelial cancer	Patient with ovarian epithelial cancer	Ovarian epithelial cancer diagnosed in 2012

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Relapse-free survival (RFS)	RFS will be assessed 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)
Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained.	2 years after diagnosis

Trial Locations

Locations (3)

Calvados registry; 🇫🇷 Caen, France

Côte d'or registry; 🇫🇷 Dijon, France

Oveval; 🇫🇷 Lyon, France