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"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"
Sponsor: Consorzio Oncotech
Summary
The study aims to establish an Italian registry for the implementation of the use of genomic tests in patients with HR +/HER2- breast cancer at intermediate risk of recurrence after the entry into force of the Ministerial Decree of 18/05/2021. The decree has established the reimbursability of genomic testing for breast cancer patients, thereby influencing clinical decision-making and patient management within Breast Units. In addition, the study aims to evaluate the clinical impact of the use of genomic testing on the type of adjuvant treatment, in terms of change of treatment indication by breast units according to the test result.
Official title: "Observational, Retrospective and Prospective, Non-interventional, Multicentre National Registry-based Study to Collect Information on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2025-03
Completion Date
2026-11
Last Updated
2025-03-13
Healthy Volunteers
Not specified
Conditions
Locations (25)
A.O. San Giuseppe Moscati
Avellino, AV, Italy
Ospedale Papa Giovanni XXIII
Bergamo, BG, Italy
Policlinico S. Orsola-Malpighi
Bologna, BO, Italy
Spedali Civili di Brescia
Brescia, BS, Italy
Asrem - Azienda Sanitaria Regionale del Molise
Termoli, CB, Italy
Azienda Ospedaliera" Sant'Anna e San Sebastiano"
Caserta, CE, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, Italy
Azienda Ospedaliero-Universitaria Arcispedale S. Anna
Ferrara, FE, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, FI, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy
IRCCS Ospedale San Raffaele
Milan, MI, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
IRCCS Humanitas Research Hospital
Rozzano, MI, Italy
IRCCS Centro di Riferimento Oncologico (C.R.O.)
Aviano, PD, Italy
Ospedale S. Stefano
Prato, PO, Italy
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, RE, Italy
Istituto Nazionale Tumori Regina Elena
Roma, RM, Italy
Ospedale Infermi di Rimini
Rimini, RN, Italy
Ospedale San Bortolo di Vicenza
Vicenza, VI, Italy
A.O.R.N. "A. Cardarelli"
Naples, Italy
AORN - Ospedali dei Colli
Naples, Italy
Azienda Ospedaliero Universitaria Federico II
Naples, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, Italy
A.O.U. Maggiore della Carità di Novara
Novara, Italy
P.O."Santa Maria delle Grazie" di Pozzuoli
Pozzuoli, Italy