Regional study into the performance and cost-effectiveness of simple ultrasound-based rules compared to the currently used Risk of Malignancy Index (RMI) in the diagnosis of ovarian cancer.
- Conditions
- ovarian cancerovarian carcinoma1003859410033283
- Registration Number
- NL-OMON41648
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
Female patients;
Diagnosed in one of the participating centers with at least one pelvic mass that is suspected to be of ovarian origin;
Patients who are to undergo surgery in order to obtain a final histological diagnosis;
Patients are 18 years of age or older.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Pregnant patients;
• Patients aged under 18 years;
• Patients in whom the surgery does not take place, or takes place more than 120 days after RMI and simple ultrasound-based rules are performed;
• Patients with a prior bilateral oophorectomy (removal of both ovaries);
• Patients with insufficient or missing data;
• Patients who do not give or are incapable of giving an informed consent;
• Patients who are not able or willing to travel to the center hospital (MUMC+ at Maastricht) for additional diagnostic procedures.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> The main study parameters are:<br /><br>1. Sensitivity;<br /><br>2. Specificity;<br /><br>3. Positive and negative predictive values; and<br /><br>3. Positive and negative likelihood ratios<br /><br>for the correct differentiation between malignant and benign adnexal masses.<br /><br>The diagnosis is based on histology (gold standard) and, in case of a<br /><br>malignancy, the surgical stage.<br /><br><br /><br>Based on the results of these study parameters a cost-effectiveness and budget<br /><br>impact analysis will be performed.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>