International Randomized Study Comparing personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70

Deliverables

Full operative imaging protocols and QA chart

Procedure explicitating the imaging protocols to be used and the QA chart

All centres ready for accrual in each country

Report on the opening of all accrual centers in the five participating countries

Approval of the web platform specifications, data collection, storage and protection by competent privacy protection authorities from each country

Approval of the data collection storage and protection by all privacy protection authorities in the five countries participating in the clinical trial

All authorisations obtained and at least one centre ready for accrual in each country

Document summarizing - of all the autorisations obtained in each country. - the opening of at least one center in each country

First study subject approvals package

a. Final version of study protocol as approved by first regulator / ethics committee(s) b. Registration number of clinical study in a WHO- or ICMJE- approved registry that also allows later posting of study results. c. Approvals required for invitation / enrolment of first subject in at least one clinical centre (if applicable): ethics committees, national competent authorities and copies of opinion or confirmation by the competent Institutional Data Protection Officer and/or authorization or notification by the National Data Protection Authority. If the position of a Data Protection Officer is established, its opinion/confirmation that all data collection and processing will be carried out according to EU and national legislation

Website and other communications tools available

The public website and the first set of communication tools dedicated to doctors and patients to publicized MyPEBS and facilitate enrollment in the trial.

First Press releases, press Kit and letters to the editor

First press release and press kit presenting MyPEBS and MyPEBS clinical trial

Publications

MyPeBS International randomized study comparing personalised, risk-stratified to standard breast cancer screening in women aged 40–70: Focus on recruitment strategy in France

Author(s): Marie-Eve Rouge-Bugat, Corinne Balleyguier, Nicolas Laurent, Anne Dautreppe, Laurine Maillet, Pascale Simon, Patrick Fournet, Christian Scellier, Thibault Menini, Emilie Darmon, Camille Baron, Cecile Vissac-Sabatier, Suzette Delaloge, on behalf of MyPeBS French investigators and of MyPeBS French Screening Coordination Structures.
Published in: La Presse Médicale Open, Issue 25902504, 2022, ISSN 2590-2504
Publisher: Elsevier BV
DOI: 10.1016/j.lpmope.2022.100022

"Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the ""My Personal Breast Screening"" (MyPeBS) randomised clinical trial."

Author(s): Alexandra Roux; Rachel Cholerton; Jonathan Sicsic; Nora Moumjid; David P. French; Paolo Giorgi Rossi; Corinne Balleyguier; Michal Guindy; Fiona J. Gilbert; Jean-Benoit Burrion; Xavier Castells; David Ritchie; Debbie Keatley; Camille Baron; Suzette Delaloge; Sandrine de Montgolfier
Published in: "BMC Cancer, BioMed Central, 2022, 22 (1), pp.507. ⟨10.1186/s12885-022-09484-6⟩", Issue 14712407, 2022, ISSN 1471-2407
Publisher: BioMed Central
DOI: 10.17863/cam.84316

Validation of a new fully automated software for 2D digital mammographic breast density evaluation in predicting breast cancer risk

Author(s): Paolo Giorgi Rossi, Olivera Djuric, Valerie Hélin, Susan Astley, Paola Mantellini, Andrea Nitrosi, Elaine F. Harkness, Emilien Gauthier, Donella Puliti, Corinne Balleyguier, Camille Baron, Fiona J. Gilbert, André Grivegnée, Pierpaolo Pattacini, Stefan Michiels & Suzette Delaloge
Published in: Scientific Reports, Issue 20452322, 2021, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-021-99433-3

Deliverables

Publications

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