An interventional study of Collection of additional data with questionnaires in Ovarian Cancer, sponsored by Institut Claudius Regaud. Completed at 10 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Health services research
The purpose of this study is to investigate the medico-economic impact of adherence to INCa (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).
This is a prospective, multicenter, comparative and non-randomized study designed to investigate the medico-economic impact of adherence to INCa guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).
A cost-utility study will be performed. It will primarily aim to assess the Incremental Cost-Utility Ratio (ICUR) at 3 years of the two treatment strategies of ovarian cancer surgery: adherence to INCa quality indicators versus non-adherence to INCa quality indicators.
Consecutive patients with stage IIIC and IV ovarian, tubal, and primary peritoneal malignancies will be recruited in different health care institutions, including comprehensive cancer centers, university hospitals and private hospitals.
Evaluation of adherence to quality indicators will be assessed retrospectively (once patients have completed the treatment) by two independent experts.
200 patients will be included over a period of 2 years and will be followed for a 3 years period after treatment (every 4 months the first two years and then every 6 months).
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient undergoing primary surgery for a newly diagnosed ovarian, tubal or peritoneal malignancies; Stage IIIc or IVa with extrapelvic carcinomatosis according to the International Federation of Gynecology and Obstetrics classification 2014
Other: Collection of additional data with questionnaires
* questionnaires for quality of life measurements: QLQC30; QLQ-OV28 * questionnaires for medico-economic purposes: ADL (activities of daily living); IADL (instrumental activities of daily living); EQ-5D3L; absenteeism questionnaire. These questionnaires will be completed during the study time (5 or 6 times during the treatment, next every 4 months during the first two years and then every 6 months during the third year of follow-up).
Cost-utility study
The primary endpoint is defined as cost per Quality-Adjusted Life Year (QALY) at 3 years. Patient utilities will be obtained from the EuroQoL 5D-3L questionnaire.
Time frame: 5 years and 6 months
Rate of institutions adherent to INCa quality indicators
The rate of institutions adherent to INCa quality indicators corresponds to the number of institutions adherent to INCa quality indicators among the total number of institutions.
Time frame: 2 years and 6 months
Rate of patients "adherent" to INCa quality indicators
The rate of patients "adherent" to INCa quality indicators corresponds to the number of patients adherent to INCa quality indicators among the total number of patients.
Time frame: 2 years and 6 months
Quality of life
The quality of life will be evaluated according to the QLQ-C30, QLQ-0V28 and the EQ-5D-3L questionnaires
Time frame: 5 years and 6 months
Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients
Budgetary impact on the health insurance budget of these INCa quality indicators on the care management of ovarian cancer patients using costs data collected from the French insurance databases, Medical Information Departments of each participating centers and from patients' questionnaires (treatment costs, other induced costs and avoided costs).
Time frame: 5 years and 6 months
Progression Free Survival
Progression Free Survival is defined as the time from inclusion until progression or death from any cause
Time frame: 5 years and 6 months
Overall Survival
Overall Survival is defined as the time from inclusion until death from any cause or last follow-up news (censored data).
Time frame: 5 years and 6 months
Morbidity
Morbidity will be assessed through recording of adverse events using NCI-CTCAE toxicity classification and vital signs measurement.
Time frame: 5 years and 6 months
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Institut Claudius Regaud