Improved Diagnosis of Ovarian Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients seen in hospitals in the Central Denmark Region during the project period.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,700 Participants
are grouped into 1 trial group
Group A: Patients with an adnexal lesion in the Central Denmark Region

Trial outcomes

Primary outcomes

1

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
2

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

1

Longitudinal changes in adnexal masses

Change in imaging characteristics, occurrence of malignancy

Time frame
Up to 5 years
2

Complications in women with conservatively managed adnexal masses

Incidence of torsion, rupture, spontaneous resolution, surgeries.

Time frame
Up to 5 years
3

Observer variability

Inter- and intra observer variation

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Aarhus University Hospital

Sponsor institution

Aarhus University Hospital

Collaborator

Regionshospitalet Horsens

Collaborator

Department of Gynaecology and Obstetrics, Viborg Regional Hospital

Collaborator

Department of Gynaecology and Obstetrics, Goedstrup Regional Hospital

Collaborator

Randers Regional Hospital

Collaborator