The MammoScreen clinical study involves 9 centres in five different European countries – Italy, Poland, Portugal, Spain and Switzerland – and will recruit 10.000 women volunteers aged between 45 and 74 years of age with an average risk of cancer.
Women will be recruited by the clinicians of each centre when they attend a scheduled breast cancer screening session and, therefore, it is not possible to submit applications to join the study.
But there are other ways of getting involved, for instance, by keeping informed about breast cancer prevention, learning about the risk of hereditary breast cancer, or by reaching out to a patient advocacy group in your country of residence.
In the clinical trial, the MammoWave technology is being investigated to confirm its ability to reach a sensibility >75% and a specificity >90%. This trial will be an open, multicentric, interventional, prospective, non-randomized clinical investigation. A dedicated electronic report form (e-CRF) was developed to optimize data acquisition and analysis in a non-biased way.
The main aim of the trial is to confirm that MammoWave, augmented by AI, reaches high sensitivity (the ability to correctly identify women with breast cancer) and specificity (the ability to correctly identify women without breast cancer). The study will be managed by a specialist third party (the Contract Research Organization, or CRO), who will work together with the clinical investigators and a medical statistician.
All the details of the study will need to be approved by the various national Ethical Committees and regulatory authorities prior to recruitment, and participants will be informed about the risks, benefits, and alternatives of the procedure in order to be able to give their informed consent.
The outcomes of the study have the potential to improve the early diagnosis of breast cancer for all women and to help improving the quality of life and health in breast cancer patients.
Our communication and dissemination activities will ensure that the relevant stakeholders are informed of the outcomes of this study, so please keep in touch through our website and social media.
This article is part of #1 issue of MAMMOSCREEN newsletter: read the full issue here.
