Improved Diagnosis of Ovarian Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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Imaging methods include ultrasonography (US) by varied observers, Magnetic Resonance Imaging (MRI) and Positron Emission Tomography-Computed Tomography (PET-CT). Imaging criteria are based on recommendations by the International Ovarian Tumor Analysis (IOTA) group. Educational efforts in IOTA terminology and systematic description at ultrasonography may support quality in the diagnostic process. Patients will be diagnosed and treated according to national and regional guidelines by the local clinicians. The project has been evaluated by the Ethical Committee in the Central Denmark Region prior to initiation. The aim of the power calculation for estimation of sample size is to be able to detect a difference in sensitivity from 75% to 90% at a threshold of 200 for Risk of Malignancy Index (RMI) and 10% for Assessment of Different NEoplasia of the adneXa (ADNEX) model and two-step-strategy / The Ovarian-Adnexal Reporting and Data System (O-RADS). To detect a difference in sensitivity (90% for ADNEX and two-step-strategy vs 75% for RMI at a specificity of 80%) at least 103 cases of malignancy should be included (calculated by using paired proportions).

Official Title
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Improved Diagnosis of Ovarian Cancer

Conditions
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Ovarian Neoplasms, Ovarian Cancer, Ovarian Cysts, Adnexal Mass, Adnexal Lesion, Adnexal Carcinoma, Adnexal Neoplasm

Participation Criteria
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Eligibility Criteria
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Patients with an adnexal mass observed at ultrasonography.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with an adnexal lesion in the Central Denmark Region<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal changes in adnexal masses | Change in imaging characteristics, occurrence of malignancy | Up to 5 years | 
| Complications in women with conservatively managed adnexal masses | Incidence of torsion, rupture, spontaneous resolution, surgeries. | Up to 5 years | 
| Observer variability | Inter- and intra observer variation | 6 months |