A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer

NCT04625023 | Recruiting DMC

• 1 other identifier: IFOM-CPO007/2019/PO006
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Number of patients recruited in TIER0 and TIER 1

  Number of recruited BC cases in TIER 0 and in TIER 1 with complete clinically annotated FFPE and/or frozen biological samples

  6 months

• Number of patients recruited in TIER2

  Number of recruited BC cases in TIER 2

  6 months

Secondary Outcomes (1)

• Number of patients triaged in proof-of concept (POC) clinical trials

  6 months

Other Outcomes (5)

• New prognostic mechanotransduction-linked markers

  6 months

• New predictive mechanotransduction-linked markers

  6 months

• Biomarkers correlation with RR

  6 months

Study Arms (1)

Cohort of BC patients

Stage-mixed cohort of at least 1500 breast cancer patients through their course of treatment, until death or a minimum of 5 years.

Other: Observational

Interventions

Observational OTHER

Retrospective cohorts and Prospective observation of standard clinical practice

Cohort of BC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage-mixed Breast Cancer (BC) patients

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.

Sponsors & Collaborators

• IFOM ETS - The AIRC Institute of Molecular Oncology: lead

Study Sites (10)

Asst Papa Giovanni Xxiii

Bergamo, Bergamo, 24127, Italy

NOT YET RECRUITING

Fondazione IRCCS, Istituto Nazionale dei Tumori

Milan, Milan, 20133, Italy

RECRUITING

Fondazione IRCCS, Istituto Neurologico Carlo Besta

Milan, Milan, 20133, Italy

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

Novara, Novara, 28100, Italy

RECRUITING

Istituto Oncologico Veneto IRCCS (IOV)

Padua, Padova, 35128, Italy

RECRUITING

Fondazione IRCCS, Policlinico San Matteo Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

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

Roma, Roma, 00144, Italy

RECRUITING

IRCCS Humanitas

Milan, 20089, Italy

RECRUITING

IEO - Istituto Europeo di Oncologia

Milan, 20141, Italy

RECRUITING

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

Reggio Emilia, 42122, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* FFPE tissue * Fresh Tissue (tumor and normal) * Plasma * PBMC * Whole Blood * Stools * Buccal Swabs * Pleural effusions and ascites

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Silvia Marsoni, MD

  IFOM ETS - The AIRC Institute of Molecular Oncology

  STUDY CHAIR

Central Study Contacts

Smeralda Rapisarda

CONTACT

+3902574303236; clinical.trials@ifom.eu

Ylenia Silvestri, PhD

CONTACT

+3902574303799; clinical.trials@ifom.eu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: July 16, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2024-09

Locations

IT (10)