Clinical trial · Observational
Prospective Validation and Comparison of Different Ultrasound Methods for Discrimination Between Benign and Malignant Ovarian/Tubal Masses Prior to Surgery
Prospective Validation and Comparison of Subjective Assessment, the International Ovarian Tumor Analysis (IOTA) ADNEX Model, Logistic Regression Model LR2, Simple Rules and the Risk of Malignancy Index (RMI) for Discrimination Between Benign and Malignant Adnexal Masses in the Hands of Ultrasound Examiners With Different Levels of Experience
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The ability of different methods to discriminate between benign and malignant adnexal masses has been compared in a meta-analysis showing that the IOTA Simple Rules and the IOTA logistic regression model LR2 were superior to RMI and to all other methods for predicting malignancy in an adnexal mass included in the meta-analysis. However, a fair comparison of methods requires them to be applied on the same tumor population. The general objective of this study is to prospectively validate the Simple Rules, ADNEX, the Simple Rules risk model, LR2, and RMI on a large multicenter dataset to allow direct comparison of these tools. IOTA7 is an international multicenter prospective observational study including different types of ultrasound centers and examiners with different levels of ultrasound experience. In total, about 1700 adnexal masses with histological outcome will be included in IOTA 7.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With Adnexal Mass Prior to Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standardized transvaginal ultrasound examination | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Sensitivity, specificity, positive and negative likelihood ratios with regard to detection of malignancy for different ultrasound methods
- timeFrame
- During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.
- measure
- AUCs for discrimination between benign and malignant masses for prediction models.
- timeFrame
- During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.
Secondary outcomes (12)
- measure
- Flexible calibration curves based on local regression (loess) to assess calibration of the estimated risks on malignancy given by the risk prediction models.
- timeFrame
- During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.
- measure
- Sensitivity, specificity, positive and negative likelihood ratios with regard to detection of malignancy for different ultrasound methods, in hands of examiners with different level of experience.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Any woman presenting with an adnexal mass judged not to be physiological and likely to undergo surgery (primarily planned for surgical management based on subjective assessment by the ultrasound examiner; however, the ultrasound examiner is allowed to change the advised management to conservative management after the results of Simple Rules or ADNEX are known). * Pregnant patients can be included but will be analysed separately. * Patients finally selected for conservative management can be included but will not be used for all statistical analyses. * For patients selected for surgery, delay of surgery is not an exclusion criterion for this study, but for selected objectives only those patients in whom surgery was performed within 180 days after the ultrasound examination will be assessed. * Patients can be selected at any age, but for patients \<18 years old, a guardian's permission should be obtained. * Patients that only underwent transabdominal scanning can be included in the study, but will be analysed separately. Exclusion Criteria: * Previous bilateral adnexectomy * Denial or withdrawal of informed consent
References
Publications (16)
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- BACKGROUNDTimmerman D. The use of mathematical models to evaluate pelvic masses; can they beat an expert operator? Best Pract Res Clin Obstet Gynaecol. 2004 Feb;18(1):91-104. doi: 10.1016/j.bpobgyn.2003.09.009. PMID 15123060
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