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
Qualifiers
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 design
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.
Treatment groups
No treatment groups listed
Sponsors and collaborators
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