Evaluating the ADNEX model for diagnosing ovarian tumors in Dutch hospitals
Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
Maxima Medical Center · NCT06103916
This study is testing if the ADNEX model can help doctors in the Netherlands tell the difference between benign and malignant ovarian tumors in patients with complex ovarian issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 613 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maxima Medical Center (other) |
| Locations | 1 site (Veldhoven, North Brabant) |
| Trial ID | NCT06103916 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective cohort study aims to assess the diagnostic accuracy of the IOTA ADNEX model in distinguishing between benign and malignant ovarian tumors in Dutch gynecological practice. Patients aged 18 and older with complex ovarian tumors who have undergone ultrasound assessments according to IOTA criteria will have their data recorded in a database. The study seeks to provide clinical data on the performance of the ADNEX model, which has shown promise in previous validation studies but needs evaluation in everyday clinical settings. The findings will help inform treatment decisions and referral practices in the Netherlands.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with complex ovarian tumors who can understand Dutch.
Not a fit: Patients with benign ovarian tumors that meet specific IOTA criteria or those with a prior histologically proven malignancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of ovarian tumor diagnoses, leading to better treatment outcomes for patients.
How similar studies have performed: Previous studies have shown the ADNEX model to have superior diagnostic accuracy compared to older risk-assessment strategies, but this study will evaluate its effectiveness in routine clinical practice.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Veldhoven, North Brabant
- Máxima Medical Centre — Veldhoven, North Brabant, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Esther Lems, MD
- Email: PRIORITY@mmc.nl
- Phone: +31 40 888 83 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Tumor, Ovarian Cancer, ultrasound, ADNEX model