Observational study. Prospective registration of ultrasound data in patients with ovarian tumors for which an ultrasound in according with the IOTA definitions is performed.
Observational study. Prospective registration of ultrasound data in patients with ovarian tumors for which an ultrasound in according with the IOTA definitions is performed.: From 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.
Study summary
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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age ≥ 18 years
2. Presence of a complex ovarian tumor
3. Ultrasound assessment in accordance with IOTA definitions and application of the ADNEX model
4. Understanding of Dutch language
Exclusion Criteria:
1. Women with an ovarian tumor that meets the IOTA criteria of a benign easy descriptor:
1. Unilocular tumor with ground glass echogenicity in premenopausal woman suggestive of endometrioma
2. Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal women (suggestive of benign cystic teratoma)
3. Unilocular tumor with regular walls and maximal diameter \< 10cm (suggestive of simple cyst or cystadenoma)
4. Remaining unilocular tumors with regular walls
2. Histologically proven malignancy prior to ultrasound
Primary outcome measure(s)
Diagnostic accuracy of the IOTA ADNEX model — 5 years (2022 - 2027) Area under the curve (AUC)
Sensitivity and specificity — 5 years (2022 - 2027) Sensitivity and specificity of the IOTA ADNEX model (%) at different thresholds
Trial sites (1)
Facility
City
Region
Status
Máxima Medical Centre
Veldhoven
North Brabant
Recruiting
More Maxima Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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