A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer

Recruiting now

Conditions studied: Breast Cancer

In brief

METAMECH is a master observational protocol designed to empower a bi-directional collaboration between basic and clinical research, an essential prerequisite to feed and implement precision oncology. METAMECH will follow a stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years. Patients will be longitudinally sampled and matched clinical data (including imaging) will be collected. Via a multi-tiered informed consensus process, METAMECH will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials.

Key facts

Study ID

NCT04625023

Run by

IFOM ETS - The AIRC Institute of Molecular Oncology

People needed

1500

Starts

2020-07-16

Expected to finish

2026-12-01

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Verification that the patient could not be reached for informed consent in accordance with applicable national regulations or, alternatively, TIER1 written Informed consent.
• Patients ≥18 years of age.
• Previous diagnosis of breast cancer, or a strong suspicion of BC based on clinical and radiological findings.
• ECOG Performance status < 2 (only for TIER1-2).

You may not qualify if…

• Any other current malignancy or malignancy diagnosed or relapsed within the past 5 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer)
• Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
• Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.

Where it is running

• Azienda U.S.L. - IRCCS di Reggio Emilia — Reggio Emilia, Italy (enrolling)
• Fondazione IRCCS, Istituto Nazionale dei Tumori — Milan, Milan, Italy (enrolling)
• Fondazione IRCCS, Istituto Neurologico Carlo Besta — Milan, Milan, Italy (enrolling)
• Azienda Ospedaliero Universitaria Maggiore della Carità di Novara — Novara, Novara, Italy (enrolling)
• Istituto Oncologico Veneto IRCCS (IOV) — Padova, Padova, Italy (enrolling)
• Fondazione IRCCS, Policlinico San Matteo Pavia — Pavia, Pavia, Italy (enrolling)
• Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO) — Roma, Roma, Italy (enrolling)
• IRCCS Humanitas — Milan, Italy (enrolling)
• IEO - Istituto Europeo di Oncologia — Milan, Italy (enrolling)
• Asst Papa Giovanni Xxiii — Bergamo, Bergamo, Italy

Full record on ClinicalTrials.gov

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