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Clinical Trials in Italy / NCT04625023
Recruiting Observational

A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer

NCT04625023 · tracked via the Priya Life Science Italy tracker
Sponsor
IFOM ETS - The AIRC Institute of Molecular Oncology
Phase
Observational
Started
2020-07-16
Last updated
2025-05-01

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Observational

Observational: Retrospective cohorts and Prospective observation of standard clinical practice

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Verification that the patient could not be reached for informed consent in accordance with applicable national regulations or, alternatively, TIER1 written Informed consent. 2. Patients ≥18 years of age. 3. Previous diagnosis of breast cancer, or a strong suspicion of BC based on clinical and radiological findings. 4. ECOG Performance status \< 2 (only for TIER1-2). Exclusion Criteria: 1. 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) 2. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons. 3. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.

Primary outcome measure(s)

  • Number of patients recruited in TIER0 and TIER 1 — 6 months
    Number of recruited BC cases in TIER 0 and in TIER 1 with complete clinically annotated FFPE and/or frozen biological samples
  • Number of patients recruited in TIER2 — 6 months
    Number of recruited BC cases in TIER 2

Trial sites (10)

FacilityCityRegionStatus
Asst Papa Giovanni Xxiii Bergamo Bergamo Not Yet Recruiting
Fondazione IRCCS, Istituto Nazionale dei Tumori Milan Milan Recruiting
Fondazione IRCCS, Istituto Neurologico Carlo Besta Milan Milan Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara Novara Novara Recruiting
Istituto Oncologico Veneto IRCCS (IOV) Padova Padova Recruiting
Fondazione IRCCS, Policlinico San Matteo Pavia Pavia Pavia Recruiting
Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO) Roma Roma Recruiting
IRCCS Humanitas Milan Italy Recruiting
IEO - Istituto Europeo di Oncologia Milan Italy Recruiting
Azienda U.S.L. - IRCCS di Reggio Emilia Reggio Emilia Italy Recruiting

More IFOM ETS - The AIRC Institute of Molecular Oncology trials in Italy

Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel Recruiting
ALFAOMEGA Master Observational Trial Recruiting
The Sagittarius Trial Recruiting
A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ) Recruiting

Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04625023 on ClinicalTrials.gov ↗ ← All trials in Italy