Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT06103916
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06103916
Study Brief:
Protocol Section:
NCT06103916