Improved Diagnosis of Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Improved Diagnosis of Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842629
• Other study ID #: adnexproject
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adnexal Carcinoma
• Adnexal Mass
• Carcinoma, Ovarian Epithelial
• Neoplasms
• Ovarian Cancer
• Ovarian Cysts
• Ovarian Neoplasms

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