International Ovarian Tumour Analysis (IOTA) Phase 7: UK Study
Research type
Research Study
Full title
International Ovarian Tumour Analysis (IOTA) Phase 7: UK Study Prospective Validation and Comparison of Subjective Assessment, ADNEX Model, Logistic Regression 2 Model, Simple Rules, and Risk of Malignancy Index for Discrimination between Benign and Malignant Adnexal Masses when Scanned by Ultrasound Examiners with Different Levels of Experience
IRAS ID
225951
Contact name
Tom Bourne
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Ovarian cancer is a common and lethal disease for which early detection and treatment in high volume centres and by specialised clinicians is known to improve survival. Hence, methods to preoperatively correctly characterise the nature of an ovarian tumour are pivotal. This study will compare the performance of one of the oldest and most commonly used methods (RMI) with the more recently developed IOTA methods when they are used by ultrasound examiners with different levels of ultrasound expertise. It will show which method(s) has/have the best performance depending on the level of experience of the ultrasound examiner. The results will lay the basis for which method(s) to recommend for clinical use by examiners with different levels of expertise. Improved discrimination between benign and malignant unilocular cysts with papillations but no other solid components has potential to substantially improve patient care.
We hypothesise that ADNEX model will be the best discriminator between benign and ovarian masses and that there will be no statistical difference between intermediate and expert scanners. Furthermore, the ADNEX model will prove an optimal method in treating women within the reproductive range conservatively and therefore not affecting their fertility potential.
In addition, there is a clear need to identify novel biomarkers for the diagnosis and management of ovarian masses. We hypothesise that using a number of different techniques that account for current information on tumour biology, diagnostic and prognostic markers for adnexal masses will be found that can be used alone or as adjuncts to currently used models.
REC name
London - Queen Square Research Ethics Committee
REC reference
17/LO/1418
Date of REC Opinion
22 Aug 2017
REC opinion
Further Information Favourable Opinion