- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02981901
Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France (Ovaire01)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Caen, France
- Calvados registry
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Dijon, France
- Côte d'or registry
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Lyon, France
- Oveval
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patient with ovarian epithelial cancer
Ovarian epithelial cancer diagnosed in 2012
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained
Time Frame: 2 years after diagnosis
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained.
Time Frame: 2 years after diagnosis
|
2 years after diagnosis
|
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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) |
2 years after diagnosis
|
Relapse-free survival (RFS)
Time Frame: RFS will be assessed 2 years after diagnosis
|
RFS will be assessed 2 years after diagnosis
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabelle RAY-COQUARD, PU-PH, Centre Leon Bérard
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- Ovaire01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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