Clinical trial · Observational
Validation of ESGO Quality Indicators in Advanced Ovarian Cancer Surgery
Assessment of the Prognostic Impact of the Published European Society of Gynecologic Oncology Quality Indicators for Advanced Ovarian Cancer Surgery
- 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)
This study, organized by the European Society of Gynaecological Oncology (ESGO), evaluates the clinical impact of adherence to ten ESGO-established quality indicators (QIs) in advanced ovarian cancer surgery. These indicators are benchmarks for high-quality surgical care, addressing aspects such as surgical completeness, multidisciplinary management, documentation, and perioperative care. The study seeks to determine how adherence to these QIs influences progression-free survival and overall survival among patients with advanced ovarian cancer. Conducted as a retrospective, international, multicenter cohort study, this research involves ESGO-accredited centers and includes data from patients treated over three years (2020-2022). The study examines two cohorts: (1) all patients newly diagnosed with FIGO stage III or IV ovarian cancer, regardless of whether surgery was part of their initial treatment, and (2) recurrent ovarian cancer patients undergoing secondary or tertiary cytoreductive surgeries. By including all consecutive cases, the study minimizes selection bias and ensures robust, real-world insights. The primary objective is to assess the association between adherence to QIs and progression-free survival. Secondary objectives include evaluating the relationship between QIs and overall survival, analyzing adherence rates to individual and collective QIs, and examining the influence of ESGO accreditation status on outcomes. Participating centers will submit pseudonymized patient data via a secure REDCap database, ensuring compliance with GDPR and other data protection regulations. This research aims to validate ESGO's QIs as effective tools for enhancing surgical outcomes and promoting best practices in gynecological oncology. Findings will support the refinement of institutional accreditation criteria, guide health policies on care centralization, and improve treatment strategies for advanced ovarian cancer patients. Ultimately, the study is expected to contribute to improved survival outcomes and establish a stronger evidence base for quality-focused surgical care in gynecological oncology.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced-stage Ovarian Cancer | — | UNRESOLVED | — |
| D010051 | — | UNRESOLVED | — |
| FIGO Stages III and IV | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Quality Indicators | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytoreductive Surgery | Procedure | — | UNRESOLVED |
| Perioperative Management | Procedure | — | UNRESOLVED |
| Preoperative Evaluations | Procedure | — | UNRESOLVED |
| Systemic Chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Newly Diagnosed Advanced Ovarian Cancer
- description
- Participants with FIGO stage III or IV ovarian cancer who were newly diagnosed and managed at ESGO-accredited centers during the study period (2020-2022). This cohort includes patients irrespective of whether they underwent cytoreductive surgery during their primary treatment.
- interventionNames
- Procedure: Preoperative Evaluations
- Procedure: Cytoreductive Surgery
- Procedure: Perioperative Management
- Procedure: Systemic Chemotherapy
- label
- Recurrent Ovarian Cancer
- description
- Participants with recurrent ovarian cancer who underwent secondary or tertiary cytoreductive surgery at ESGO-accredited centers during the study period (2020-2022). This cohort focuses on evaluating surgical and clinical outcomes in cases of disease recurrence.
- interventionNames
- Procedure: Preoperative Evaluations
- Procedure: Cytoreductive Surgery
- Procedure: Perioperative Management
- Procedure: Systemic Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient presented at an ESGO-accredited centre between January 1, 2020 and December 31, 2022 * Newly diagnosed FIGO stage III or IV ovarian cancer (surgical and non-surgical cases), OR * Relapsed ovarian cancer undergoing secondary or tertiary cytoreductive surgery (surgical cases only) * All consecutive incoming ovarian cancer patients within the specified time frame were documented to avoid selection bias Exclusion Criteria: * Age \<18 years at first diagnosis * Relapsed ovarian cancer undergoing surgery for palliative intent (no cytoreductive surgery) * Early-stage ovarian cancer at first diagnosis
References
Publications (8)
- BACKGROUNDWright JD, Chen L, Hou JY, Burke WM, Tergas AI, Ananth CV, Neugut AI, Hershman DL. Association of Hospital Volume and Quality of Care With Survival for Ovarian Cancer. Obstet Gynecol. 2017 Sep;130(3):545-553. doi: 10.1097/AOG.0000000000002164. PMID 28796677
- BACKGROUNDQuerleu D, Planchamp F, Chiva L, Fotopoulou C, Barton D, Cibula D, Aletti G, Carinelli S, Creutzberg C, Davidson B, Harter P, Lundvall L, Marth C, Morice P, Rafii A, Ray-Coquard I, Rockall A, Sessa C, van der Zee A, Vergote I, du Bois A. European Society of Gynaecologic Oncology Quality Indicators for Advanced Ovarian Cancer Surgery. Int J Gynecol Cancer. 2016 Sep;26(7):1354-63. doi: 10.1097/IGC.0000000000000767. PMID 27648648
- BACKGROUNDPalmqvist C, Staf C, Mateoiu C, Johansson M, Albertsson P, Dahm-Kahler P. Increased disease-free and relative survival in advanced ovarian cancer after centralized primary treatment. Gynecol Oncol. 2020 Nov;159(2):409-417. doi: 10.1016/j.ygyno.2020.09.004. Epub 2020 Sep 15. PMID 32943206
- BACKGROUNDMarth C, Abreu MH, Andersen KK, Aro KM, de Lurdes Batarda M, Boll D, Ekmann-Gade AW, Haltia UM, Hansen J, Haug AJ, Hogdall C, Korach J, Lassus H, Lindemann K, Van Nieuwenhuysen E, Ottevanger PB, Polterauer S, Schnack TH. Real-life data on treatment and outcomes in advanced ovarian cancer: An observational, multinational cohort study (RESPONSE trial). Cancer. 2022 Aug 15;128(16):3080-3089. doi: 10.1002/cncr.34350. Epub 2022 Jun 17. PMID 35714310
- BACKGROUNDGac MM, Loaec C, Silve J, Vaucel E, Augereau P, Wernert R, Bourgin C, Aireau X, Lortholary A, Descamps P, Priou F, Deblaye P, Bourgeois H, Delecroix V, Empereur F, Campion L, Classe JM. Quality of advanced ovarian cancer surgery: A French assessment of ESGO quality indicators. Eur J Surg Oncol. 2021 Feb;47(2):360-366. doi: 10.1016/j.ejso.2020.08.003. Epub 2020 Aug 11. PMID 32863097
- BACKGROUNDFotopoulou C, Concin N, Planchamp F, Morice P, Vergote I, du Bois A, Querleu D. Quality indicators for advanced ovarian cancer surgery from the European Society of Gynaecological Oncology (ESGO): 2020 update. Int J Gynecol Cancer. 2020 Apr;30(4):436-440. doi: 10.1136/ijgc-2020-001248. Epub 2020 Feb 20. No abstract available.