NCT04625023 A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer
| NCT ID | NCT04625023 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IFOM ETS - The AIRC Institute of Molecular Oncology |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2020-07-16 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2020-07-16 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Silvia Marsoni, MD
STUDY CHAIR
IFOM ETS - The AIRC Institute of Molecular Oncology
Frequently Asked Questions
Who can join the NCT04625023 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04625023 currently recruiting?
Yes, NCT04625023 is actively recruiting participants. Contact the research team at clinical.trials@ifom.eu for enrollment information.
Where is the NCT04625023 trial being conducted?
This trial is being conducted at Bergamo, Italy, Milan, Italy, Milan, Italy, Novara, Italy and 6 additional locations.
Who is sponsoring the NCT04625023 clinical trial?
NCT04625023 is sponsored by IFOM ETS - The AIRC Institute of Molecular Oncology. The principal investigator is Silvia Marsoni, MD at IFOM ETS - The AIRC Institute of Molecular Oncology. The trial plans to enroll 1,500 participants.
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