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A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer

RECRUITINGSponsored by IFOM ETS - The AIRC Institute of Molecular Oncology
Actively Recruiting
SponsorIFOM ETS - The AIRC Institute of Molecular Oncology
Started2020-07-16
Est. completion2026-07
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Breast CancerCancer

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