A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer
IFOM ETS - The AIRC Institute of Molecular Oncology
1,500 participants
Jul 16, 2020
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
Inclusion Criteria4
- 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).
Exclusion Criteria3
- 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.
Interventions
Retrospective cohorts and Prospective observation of standard clinical practice
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04625023