Clinical trial NCT05842629: Improved Diagnosis of Ovarian Cancer
Official title: Improved Diagnosis of Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Neoplasms
Ovarian Cancer
Ovarian Cysts
Adnexal Mass
Adnexal Lesion
Adnexal Carcinoma
Adnexal Neoplasm
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Horsens
name: Department of Gynaecology and Obstetrics, Viborg Regional Hospital
name: Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital
name: Department of Gynaecology and Obstetrics, Randers Regional Hospital
First posted: 2023-05-06
Enrollment: 1700
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seen in hospitals in the Central Denmark Region during the project period.

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).

Eligibility criteria: Patients with an adnexal mass observed at ultrasonography.

Primary outcomes:
measure: Diagnostic efficiency of available imaging modalities by models and subjective evaluation for pre-operative diagnosis of adnexal masses
timeFrame: 6 months
measure: Area Under the Receiver Operating Characteristic Curve of ADNEX, O-RADS, two-step-strategy, Simple Rules and Risk of Malignancy Index.
timeFrame: 6 months
Secondary outcomes:
measure: Longitudinal changes in adnexal masses
timeFrame: Up to 5 years
measure: Complications in women with conservatively managed adnexal masses
timeFrame: Up to 5 years
measure: Observer variability
timeFrame: 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Gynaecology and Obstetrics, Aarhus University Hospital
Study officials:
affiliation: University of Aarhus
name: Ina Marie Dueholm Hjorth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Ole Mogensen, DMSci
role: STUDY_DIRECTOR
References: