Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France (Ovaire01)

August 22, 2018 updated by: Centre Leon Berard

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

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Calvados registry
      • Dijon, France
        • Côte d'or registry
      • Lyon, France
        • Oveval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with ovarian epithelial cancer diagnosed in 2012

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Patient with ovarian epithelial cancer

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
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 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

Cancer Côte d'or registry
Cancer Calvados registry

Investigators

  • Principal Investigator: Isabelle RAY-COQUARD, PU-PH, Centre Leon Berard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

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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