Status:
RECRUITING
Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice
Lead Sponsor:
Maxima Medical Center
Collaborating Sponsors:
Radboud University Medical Center
The Netherlands Cancer Institute
Conditions:
Ovarian Tumor
Ovarian Cancer
Eligibility:
FEMALE
18+ years
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 app...
Detailed Description
Rationale: Correct pre-operative classification of ovarian tumors is critical for optimal treatment of both women with benign and malignant ovarian tumors. The International Ovarian Tumor Analysis (IO...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Histologically proven malignancy prior to ultrasound
Key Trial Info
Start Date :
July 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
613 Patients enrolled
Trial Details
Trial ID
NCT06103916
Start Date
July 15 2022
End Date
May 1 2028
Last Update
October 27 2023
Active Locations (1)
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1
Máxima Medical Centre
Veldhoven, North Brabant, Netherlands, 5504 DB