RecruitingNCT04625023

A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer


Sponsor

IFOM ETS - The AIRC Institute of Molecular Oncology

Enrollment

1,500 participants

Start Date

Jul 16, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting breast tissue samples and data from breast cancer patients to study the physical forces (mechanobiology) within tumors — including how stiff or soft the tissue is — to better understand how cancer grows and spreads. This is a research collection study, not a treatment trial. **You may be eligible if...** - You are 18 or older - You have a confirmed or strongly suspected breast cancer diagnosis based on clinical and imaging findings - You are in reasonably good functional health (for certain study tiers) - You consent to tissue and data collection **You may NOT be eligible if...** - You have another active cancer or a cancer diagnosis or relapse within the past 5 years (except early skin cancers or in-situ cervical cancer) - You have HIV, Hepatitis B, or Hepatitis C infection - You are unable to comply with study procedures due to personal, social, or geographic reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERObservational

Retrospective cohorts and Prospective observation of standard clinical practice


Locations(10)

Asst Papa Giovanni Xxiii

Bergamo, Bergamo, Italy

Fondazione IRCCS, Istituto Nazionale dei Tumori

Milan, Milan, Italy

Fondazione IRCCS, Istituto Neurologico Carlo Besta

Milan, Milan, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Novara, Novara, Italy

Istituto Oncologico Veneto IRCCS (IOV)

Padova, Padova, Italy

Fondazione IRCCS, Policlinico San Matteo Pavia

Pavia, Pavia, Italy

Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO)

Roma, Roma, Italy

IRCCS Humanitas

Milan, Italy

IEO - Istituto Europeo di Oncologia

Milan, Italy

Azienda U.S.L. - IRCCS di Reggio Emilia

Reggio Emilia, Italy

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NCT04625023


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