About this trial
After implementation of systematic image description of adnexal masses, we aim to improve and evaluate our use of available imaging methods and biomarkers for classifying adnexal masses and distinguishing between benign and malignant adnexal masses in the hands of clinicians in Central Denmark Region.
Secondarily, we want to improve our management of adnexal masses by evaluating the complications and longitudinal changes in conservatively managed adnexal masses.
Data is registered prospectively but analyzed retrospectively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients seen in hospitals in the Central Denmark Region during the project period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Diagnostic efficiency of available imaging modalities by models and subjective evaluation for pre-operative diagnosis of adnexal masses
Accuracy measures for diagnosis of ovarian cancer: Sensitivity, specificity, positive and negative predictive values.
Area Under the Receiver Operating Characteristic Curve of ADNEX, O-RADS, two-step-strategy, Simple Rules and Risk of Malignancy Index.
Comparison of AUC's between models/strategies
Secondary outcomes
Longitudinal changes in adnexal masses
Change in imaging characteristics, occurrence of malignancy
Complications in women with conservatively managed adnexal masses
Incidence of torsion, rupture, spontaneous resolution, surgeries.
Observer variability
Inter- and intra observer variation
Sponsors and contacts
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Sponsor institution
Aarhus University Hospital
Collaborator
Regionshospitalet Horsens
Collaborator
Department of Gynaecology and Obstetrics, Viborg Regional Hospital
Collaborator
Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital
Collaborator
Randers Regional Hospital
Collaborator