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 Different Ultrasound Methods for Discrimination Between Benign and Malignant Ovarian/Tubal Masses Prior to Surgery
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.
Ovarian cancer is a common and lethal disease for which early detection and treatment in high
 volume centers and by specialized clinicians is known to improve survival. Hence, accurate
 methods to preoperatively characterize the nature of an ovarian tumor are pivotal.

 The best ultrasound method for discrimination between benign and malignant adnexal masses is
 subjective assessment, i.e. subjective evaluation of ultrasound findings. Subjective
 assessment, however, requires a very experienced ultrasound examiner. More objective methods
 may be preferred by less experienced examiners who are not confident with using subjective
 assessment. The Risk of Malignancy Index (RMI) is one such method. There are also more
 recently developed methods. The International Ovarian Tumor Analysis (IOTA) group have
 created logistic regression models (LR1, LR2, and the ADNEX model) including clinical and
 ultrasound information to calculate the likelihood of malignancy in adnexal masses.

 The IOTA group has also suggested simple ultrasound rules that can be used to classify
 adnexal masses as benign or malignant.

 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. The patients will be examined by operators of varying levels of
 experience, such that the investigators can study how experience might affect diagnostic
 performance.

 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.

 Patients with a known or suspected adnexal mass examined with transvaginal (or transrectal if
 vaginal is not possible) ultrasound by an IOTA certified ultrasound examiner and confirmed to
 have an adnexal mass judged not to be physiological but likely to undergo surgery (primarily
 planned for surgical management based on subjective assessment by the ultrasound
 investigator) will be recruited consecutively Upon inclusion in the study, an oral or written
 (depending on the requirements of the local Ethics Committee) informed consent is obtained
 from the patient.

 Data collection is done through the web-based clinical data miner (CDM) software. Data are
 stored on a secure server.

 First, clinical information about the patient is entered into CDM. Second, the ultrasound
 examiner provides a diagnosis based on subjective assessment, and notes the suggested
 management. Third, detailed ultrasound information needed for the different models to be
 validated is entered. When these data have been frozen (so they can no longer be changed) the
 examiner gets access to the results of the Simple Rules and ADNEX. The ultrasound examiner
 then records whether these results make him/her change the management suggested on the basis
 of subjective assessment. If so the new management is specified.

 Gold standard for validation of discriminative ability and calibration is the histology of
 the adnexal mass within 180 days after the ultrasound examination following surgical removal
 by laparotomy or laparoscopy as considered appropriate by the surgeon. In case of malignancy,
 the stage of the malignant tumors using the classification of the International Federation of
 Gynecology and Obstetrics (FIGO) is noted.
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