Clinical trial · Observational
Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
NCT06103916CI-TRIAL-00070855PRIORITYrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Tumor | Ovarian Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Diagnostic accuracy of the IOTA ADNEX model
- timeFrame
- 5 years (2022 - 2027)
- description
- Area under the curve (AUC)
- measure
- Sensitivity and specificity
- timeFrame
- 5 years (2022 - 2027)
- description
- Sensitivity and specificity of the IOTA ADNEX model (%) at different thresholds
Secondary outcomes (1)
- measure
- Factors influencing the diagnostic performance of the IOTA ADNEX model
- timeFrame
- 5 years (2022 - 2027)
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.