Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMaxima Medical Center
About this trial
Multicenter prospective cohort study in which patients ≥18 years with an ovarian tumor for which an ultrasound has been performed in accordance with IOTA criteria and the IOTA ADNEX model has been applied are included. Ultrasound data from these patients will be prospectively recorded in a database to determine the diagnostic accuracy of the IOTA ADNEX model in Dutch gynaecological practice.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Presence of a complex ovarian tumor
Ultrasound assessment in accordance with IOTA definitions and application of the ADNEX model
Understanding of Dutch language
Disqualifiers
Unilocular tumor with ground glass echogenicity in premenopausal woman suggestive of endometrioma
Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal women (suggestive of benign cystic teratoma)
Unilocular tumor with regular walls and maximal diameter < 10cm (suggestive of simple cyst or cystadenoma)
Remaining unilocular tumors with regular walls
Trial population
Women (age ≥ 18 years) presenting with an ovarian tumor that does not meet one of the IOTA criteria of a benign easy descriptor
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational study. Prospective registration of ultrasound data in patients with ovarian tumors for which an ultrasound in according with the IOTA definitions is performed.
Other interventionFrom all included patients, prospective data will be collected of the ultrasound(s) performed, the performed treatment and in case of surgery also the final pathological diagnosis. Participating patients will not be subjected to acts or additional procedures or examinations in this study, nor will rules of conduct be imposed.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of the IOTA ADNEX model
Area under the curve (AUC)
Time frame
5 years (2022 - 2027)2
Sensitivity and specificity
Sensitivity and specificity of the IOTA ADNEX model (%) at different thresholds
Time frame
5 years (2022 - 2027)Secondary outcomes
1
Factors influencing the diagnostic performance of the IOTA ADNEX model
Influence on the diagnostic performance of the type of center, volume per center, prevalence of malignancy, experience of ultrasound performer, availability of consultation time specifically aimed at performing ultrasounds according to IOTA criteria
Time frame
5 years (2022 - 2027)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Maxima Medical Center
Lead sponsor
Radboud University Medical Center
Collaborator
The Netherlands Cancer Institute
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov