Improved Diagnosis of Ovarian Cancer

Recruiting

• Conditions: Adnexal Lesion; Adnexal Neoplasm; Adnexal Mass; Ovarian Cancer; Ovarian Cysts; Adnexal Carcinoma; Ovarian Neoplasms

• Registration Number: NCT05842629
• Lead Sponsor: University of Aarhus

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-05-15
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-06
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-06
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic efficiency of available imaging modalities by models and subjective evaluation for pre-operative diagnosis of adnexal masses	6 months	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.	6 months	Comparison of AUC's between models/strategies

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Gynaecology and Obstetrics, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark