Clinical trial · Interventional
Cost Utility of Radical Surgery in Ovarian Cancer
NCT02854215CI-TRIAL-00108104CURSOCcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of additional data with questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Ovarian cancer
- description
- 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
- interventionNames
- Other: Collection of additional data with questionnaires
Primary outcomes (1)
- measure
- Cost-utility study
- timeFrame
- 5 years and 6 months
- description
- 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.
Secondary outcomes (7)
- measure
- Rate of institutions adherent to INCa quality indicators
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Woman with age ≥ 18 years. * 2\. Newly diagnosed ovarian, tubal or peritoneal malignancies. * 3\. Epithelial histology. * 4\. Stage IIIC or IVA with extrapelvic carcinomatosis according to FIGO classification 2014. * 5\. Patients undergoing primary surgery or neoadjuvant chemotherapy. * 6\. Performance Status ≤ 2. * 7\. Patient affiliated to a Social Health Insurance in France. * 8\. Patient information and informed consent form signed prior to any study specific procedures. Exclusion Criteria: * 1\. Benign or borderline tumors. * 2\. Patients with extra-abdominal disease, except for pleural effusion with positive cytology. * 3\. Other malignancy diagnosed in the previous 5 years except skin cancer (other than melanoma). * 4\. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. * 5\. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
References
Publications (2)
- BACKGROUNDAlejandra M, Gertych W, Pomel C, Ferron G, Lusque A, Angeles MA, Lambaudie E, Rouzier R, Bakrin N, Golfier F, Glehen O, Canis M, Bourdel N, Pouget N, Colombo PE, Guyon F, Meurette J, Querleu D. Adherence to French and ESGO Quality Indicators in Ovarian Cancer Surgery: An Ad-Hoc Analysis from the Prospective Multicentric CURSOC Study. Cancers (Basel). 2021 Mar 30;13(7):1593. doi: 10.3390/cancers13071593. PMID 33808284
- DERIVEDFilleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30. PMID 29608972