Prospective Validation and Comparison of Different Ultrasound Methods for Discrimination Between Benign and Malignant Ovarian/Tubal Masses Prior to Surgery

NCT02847832UNKNOWNOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

KU Leuven

Enrollment

1700

Start Date

2016-10-01

Completion Date

2020-12-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Standardized transvaginal ultrasound examination

Conditions

Patients With Adnexal Mass Prior to Surgery

Eligibility

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Sensitivity, specificity, positive and negative likelihood ratios with regard to detection of malignancy for different ultrasound methods

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

AUCs for discrimination between benign and malignant masses for prediction models.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

Secondary Outcomes

Flexible calibration curves based on local regression (loess) to assess calibration of the estimated risks on malignancy given by the risk prediction models.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

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.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

AUCs for prediction models, in hands of examiners with different level of experience.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

Sensitivity, specificity, positive and negative likelihood ratios with regard to detection of malignancy for different ultrasound methods, where the Simple Rules are inconclusive.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

AUCs for prediction models, where the Simple Rules are inconclusive.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

Change of the suggested management based on subjective assessment depending on the level of expertise of the ultrasound examiner, after results of the Simple Rules have been shown.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

Polytomous discrimination index for the ADNEX model to discriminate between different classes of histology.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

AUCs for each pair of outcome categories using the conditional risk method for the ADNEX model to discriminate between different classes of histology.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

Multinomial calibration curves for the ADNEX model to predict benign tumors, borderline tumors, stage 1 primary ovarian cancer, stage 2-4 primary ovarian cancer and metastatic cancer.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

Adjusted odds ratios with regard to malignancy for selected ultrasound characteristics, mainly papillation characteristics, in the subgroup of unilocular cysts with papillations.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

Sensitivity and specificity with regard to malignancy at different risk cutoffs, for a risk prediction model in unilocular cysts with papillations based on a limited number of variables selected a priori.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

AUC for a risk prediction model in unilocular cysts with papillations based on a limited number of variables selected a priori.

Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 180 days after ultrasound examination.

Locations

University Hospitals Leuven, Leuven, Belgium

Prospective Validation and Comparison of Different Ultrasound Methods for Discrimination Between Benign and Malignant Ovarian/Tubal Masses Prior to Surgery