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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 613 participants in total. It began in 2022-07-15 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06103916 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06103916 currently recruiting?
Yes, NCT06103916 is actively recruiting participants. Contact the research team at PRIORITY@mmc.nl for enrollment information.
Where is the NCT06103916 trial being conducted?
This trial is being conducted at Veldhoven, Netherlands.
Who is sponsoring the NCT06103916 clinical trial?
NCT06103916 is sponsored by Maxima Medical Center. The trial plans to enroll 613 participants.