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Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice

Recruitingn/aAges 18 Years - anyFemaleMaxima Medical Center
NCT06103916 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Observational study. Prospective registration of ultrasound data in patients with ovarian tumors for which an ultrasound in according with the IOTA definitions is performed.
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Where

1 site
Máxima Medical Centre
Veldhoven, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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