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NCT02981901 Clinical Trial

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

Ovarian Epithelial Cancer Clinical Trial

— Ovaire01  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02981901
Other study ID # Ovaire01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2017
Est. completion date December 2019

Study information
Verified date August 2018
Source Centre Leon Berard
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 376
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Patient with ovarian epithelial cancer

Locations
Country Name City State
France Calvados registry Caen
France Côte d'or registry Dijon
France Oveval Lyon

Sponsors (3)
Lead Sponsor Collaborator
Centre Leon Berard Cancer Calvados registry, Cancer Côte d'or registry

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained To perform a cost-effectiveness analysis in order to evaluate the most efficient organization for ovarian cancer in 1st line ot treatment 2 years after diagnosis
Secondary Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained. 2 years after diagnosis
Secondary Budget impact analysis 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)		 2 years after diagnosis
Secondary Relapse-free survival (RFS) RFS will be assessed 2 years after diagnosis
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