Actively Recruiting
Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
Led by Maxima Medical Center · Updated on 2023-10-27
613
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
Sponsors
M
Maxima Medical Center
Lead Sponsor
R
Radboud University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presence of a complex ovarian tumor
- Ultrasound assessment performed according to IOTA definitions with ADNEX model applied
- Ability to understand Dutch language
You will not qualify if you...
- Ovarian tumors classified as benign by IOTA 'easy descriptor' criteria, including:
- Unilocular tumor with ground glass echogenicity in premenopausal women 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 maximum diameter less than 10 cm suggestive of simple cyst or cystadenoma
- Other unilocular tumors with regular walls
- Histologically confirmed malignancy before ultrasound
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Máxima Medical Centre
Veldhoven, North Brabant, Netherlands, 5504 DB
Actively Recruiting
Research Team
E
Esther Lems, MD
CONTACT
P
Peggy Geomini, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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