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NOT YET RECRUITING
NCT06871501

"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

View on ClinicalTrials.gov

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