Ovarian Cancer Clinical Trial
Official title:
Improved Diagnosis of Ovarian Cancer
NCT number | NCT05842629 |
Other study ID # | adnexproject |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2021 |
Est. completion date | December 2028 |
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.
Status | Recruiting |
Enrollment | 1700 |
Est. completion date | December 2028 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Patients with an adnexal mass observed at ultrasonography. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Gynaecology and Obstetrics, Aarhus University Hospital | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Department of Clinical Medicine, Aarhus University, Department of Gynaecology and Obstetrics, Aarhus University Hospital, Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital, Department of Gynaecology and Obstetrics, Horsens Regional Hospital, Department of Gynaecology and Obstetrics, Randers Regional Hospital, Department of Gynaecology and Obstetrics, Viborg Regional Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Longitudinal changes in adnexal masses | Change in imaging characteristics, occurrence of malignancy | Up to 5 years | |
Secondary | Complications in women with conservatively managed adnexal masses | Incidence of torsion, rupture, spontaneous resolution, surgeries. | Up to 5 years | |
Secondary | Observer variability | Inter- and intra observer variation | 6 months |
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