Trials / Recruiting
RecruitingNCT05842629
Improved Diagnosis of Ovarian Cancer
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,700 (estimated)
- Sponsor
- University of Aarhus · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
- Ovarian Neoplasms
- Ovarian Cancer
- Ovarian Cysts
- Adnexal Mass
- Adnexal Lesion
- Adnexal Carcinoma
- Adnexal Neoplasm
Timeline
- Start date
- 2021-05-15
- Primary completion
- 2024-06-01
- Completion
- 2028-12-01
- First posted
- 2023-05-06
- Last updated
- 2024-05-09
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05842629. Inclusion in this directory is not an endorsement.