Clinical trial · Interventional
Validation of a Laparoscopic Score to Predict the Chance of Optimal Cytoreduction in Advanced Ovarian Cancer Patients
Olympia-MITO13-validation of a Laparoscopic Score to Predict the Chance of Optimal Cytoreduction in Advanced Ovarian Cancer Patients: an Open-label Prospective Multicentric-trial.
- 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)
Prospective multicenter study that aims to evaluate the learning curve of a laparoscopic score to predict possibility of optimal cytoreduction in patients with ovarian / tubal / peritoneal advanced at the time of first surgery. The study consists of subjecting all patients with a clinical suspicion and / or radiological diagnostic laparoscopy (SLPs). Laparoscopy should be described and recorded in electronic form. After the procedure each patient will have a Laparoscopic-evaluation-form filled up with a laparoscopic score (PI). The minimum number of cases to be enrolled is 10 patients, in a minimum time of 1 year. The data collected and the video should be sent to the Center Coordinator, who will determine the adequacy of the procedure and the accuracy of the score enrollment is completed for each center. All eligible subjects will be considered by intention-to-treat population (ITT). For this phase of the study, it is not necessary know the outcome of the surgical patient (RT) or if it was then subjected to exploratory laparotomy or less.
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 |
|---|---|---|---|
| Cancer of Ovary | Malignant Ovarian Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic laparoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic Laparoscopy
- description
- Laparoscopy will be performed in each case of clinical/radiological suspicious primary advanced ovarian/peritoneal cancer.
- interventionNames
- Procedure: Diagnostic laparoscopy
Primary outcomes (1)
- measure
- a prospective and multicentric validation of the laparoscopic score (PI), developed at the Catholic University of the Sacred Hearth (UCSC), to predict surgical outcome in primary AOC patients
- timeFrame
- 2 years
- description
- The primary objective of this study is to obtain a prospective and multicentric validation of the laparoscopic score (PI), developed at the Catholic University of the Sacred Hearth (UCSC), to predict surgical outcome in primary AOC patients. In particular, we want to identify the PI cut-off value, at which AOC patients can be reasonably considered not optimally resectable (RT\< 1 cm) in an expert referring centre for AOC treatment, thus avoiding an unnecessary exploratory xipho-pubic laparotomy.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Patients with a diagnosis suspect for advanced ovarian cancer (FIGO stage III-IV) * Life expectancy of at least 4 weeks * Performance Status ≤ 2 * Adequate respiratory, hepatic, cardiological, medullar and renal function (Creatinine Clearance \> 60 mL/min according to Cockcroft's formula) * Compliant patient with psychological ability to follow the study procedures Exclusion Criteria: * Pregnancy or nursing. * Inadequate respiratory, hepatic, cardiological, medullar and renal function, that avoid safe surgery. * Patients with cancer mass occupying the entire abdomen or infiltrating abdominal wall.
References
Publications (0)
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