NCT06103916Recruiting
Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
Source: ClinicalTrials.gov · Last updated 27 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 613 (estimated)
- First submitted
- 12 Jan 2022
- Start date
- 15 Jul 2022
- Primary completion date
- Aug 2027
- Lead sponsor
- Maxima Medical Center
- Diseases
- Ovarian cancer
- NCT number
- NCT06103916
What you commit to
- Study type: Observational
- Planned participants: 613
- From 15 Jul 2022 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Histologically proven malignancy prior to ultrasound
Other
- Women with an ovarian tumor that meets the IOTA criteria of a benign easy descriptor:
- Unilocular tumor with ground glass echogenicity in premenopausal woman suggestive of endometrioma
- Unilocular tumor with mixed echogenicity and acoustic shadows in premenopausal women (suggestive of benign cystic teratoma)
- Unilocular tumor with regular walls and maximal diameter \< 10cm (suggestive of simple cyst or cystadenoma)
- Remaining unilocular tumors with regular walls
Who the study is looking for
- Age ≥ 18 years
- Presence of a complex ovarian tumor
- Ultrasound assessment in accordance with IOTA definitions and application of the ADNEX model
- Understanding of Dutch language
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maxima Medical Centre Coordinator of this site? Confirm its status | Veldhoven | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.