An observational study in Patients With Adnexal Mass Prior to Surgery, sponsored by KU Leuven. Status unknown at 1 site in Belgium. Open to female participants. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by KU Leuven · Observational
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 1,700 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
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Consecutive 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).
Different types of ultrasound centers (general gynecologic outpatient clinic or specialized ultrasound centers) and examiners with different levels of ultrasound experience will be involved.
Exclusion Criteria:
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.
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.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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