Ovarian Epithelial CancerOvaire01NCT02981901
Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France
An observational study of Ovarian Epithelial Cancer, run by Centre Leon Berard at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Epithelial Cancer
- What is being tested?
- Patient with ovarian epithelial cancer
- How many people
- 376 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2017to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with ovarian epithelial cancer diagnosed in 2012
Who may be able to join
- 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
Who cannot join
- Relapsed ovarian epithelial cancer
- Non epithelial ovarian cancer
Trial locations and contacts
3 sites in 1 country.
About this study
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.
- Conditions
- Ovarian Epithelial Cancer
- Being tested
- Patient with ovarian epithelial cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient with ovarian epithelial cancerOther
| Study group | Role | What they receive |
|---|---|---|
| Patient with ovarian epithelial cancer | Ovarian epithelial cancer diagnosed in 2012 Receives: Other: Patient with ovarian epithelial cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after diagnosis
Secondary outcomes (3)
Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained.
Measured: 2 years after diagnosis
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)
Measured: 2 years after diagnosis
Relapse-free survival (RFS)
Measured: RFS will be assessed 2 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Epithelial CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Côte d'or registry, Cancer Calvados registry
- Responsible party
- Sponsor
- Investigators
- Isabelle RAY-COQUARD, PU-PH, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981901
- Sponsor's protocol ID
- Ovaire01
- Acronym
- Ovaire01
- Status last verified
- Aug 2018
- First submitted
- 28 Nov 2016
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France
- ClinicalTrials.gov ID
- NCT02981901
- Acronym / sponsor ID
- Ovaire01 / Ovaire01
- Conditions
- Ovarian Epithelial Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Cancer Côte d'or registry, Cancer Calvados registry
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with ovarian epithelial cancer | – | Other: Patient with ovarian epithelial cancerOvarian epithelial cancer diagnosed in 2012 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with ovarian epithelial cancer diagnosed in 2012
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Relapsed ovarian epithelial cancer
- Non epithelial ovarian cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient with ovarian epithelial cancer | Other | Patient with ovarian epithelial cancer |
Primary outcome
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
3 secondary outcomes
Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained.
Time frame: 2 years after diagnosis
Budget impact analysis
Time frame: 2 years after diagnosis
Relapse-free survival (RFS)
Time frame: RFS will be assessed 2 years after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle RAY-COQUARD, PU-PH principal investigator
Centre Leon Berard
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Epithelial Cancer, run by Centre Leon Berard at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained (time frame: 2 years after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.