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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source University of Aarhus
Contact Ina Marie Dueholm Hjorth, MD
Phone +004526192456
Email imhjorth@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
Denmark Department of Gynaecology and Obstetrics, Aarhus University Hospital Aarhus

Sponsors (7)

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

Country where clinical trial is conducted

Denmark, 

Outcome

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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