NCT06103916 Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
| NCT ID | NCT06103916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maxima Medical Center |
| Condition | Ovarian Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 613 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2027-08 |
Trial Parameters
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Brief 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 Criteria
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