Patients With Adnexal Mass Prior to Surgery Clinical Trial
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
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.
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