Improved Diagnosis of Ovarian Cancer

NCT05842629RecruitingOBSERVATIONAL

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.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

1700

Start Date

2021-05-15

Completion Date

2024-06-01

Study Type

OBSERVATIONAL

Official Title

Improved Diagnosis of Ovarian Cancer

Conditions

Ovarian NeoplasmsOvarian CancerOvarian CystsAdnexal MassAdnexal LesionAdnexal CarcinomaAdnexal Neoplasm

Eligibility

Sex

FEMALE

Patients with an adnexal mass observed at ultrasonography.

Outcome Measures

Primary Outcomes

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.

Time frame: 6 months

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

Time frame: 6 months

Secondary Outcomes

Longitudinal changes in adnexal masses

Change in imaging characteristics, occurrence of malignancy

Time frame: Up to 5 years

Complications in women with conservatively managed adnexal masses

Incidence of torsion, rupture, spontaneous resolution, surgeries.

Time frame: Up to 5 years

Observer variability

Inter- and intra observer variation

Time frame: 6 months

Locations

Department of Gynaecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.