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Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
RECRUITINGSponsored by Maxima Medical Center
Actively Recruiting
SponsorMaxima Medical Center
Started2022-07-15
Est. completion2027-08
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06103916
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
Age: 18 Years+Sex: FEMALEHealthy 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
Conditions3
CancerOvarian CancerOvarian Tumor
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Actively Recruiting
SponsorMaxima Medical Center
Started2022-07-15
Est. completion2027-08
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06103916