Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France
Ovaire01
1 other identifier
observational
376
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 23, 2018
August 1, 2018
2.9 years
November 28, 2016
August 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Relapse-free survival (RFS)
RFS will be assessed 2 years after diagnosis
Study Arms (1)
Patient with ovarian epithelial cancer
Ovarian epithelial cancer diagnosed in 2012
Interventions
Eligibility Criteria
Women with ovarian epithelial cancer diagnosed in 2012
You may qualify if:
- 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
You may not qualify if:
- Relapsed ovarian epithelial cancer
- Non epithelial ovarian cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Leon Berardlead
- Cancer Côte d'or registrycollaborator
- Cancer Calvados registrycollaborator
Study Sites (3)
Calvados registry
Caen, France
Côte d'or registry
Dijon, France
Oveval
Lyon, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle RAY-COQUARD, PU-PH
Centre Leon Berard
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2016
First Posted
December 5, 2016
Study Start
January 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
August 23, 2018
Record last verified: 2018-08