Observational study on mechanobiology in breast cancer
A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer
This study is looking at how breast cancer cells interact with the body to see if understanding these relationships can help improve treatment outcomes for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IFOM ETS - The AIRC Institute of Molecular Oncology Academic / other |
| Locations | 10 sites (Bergamo, Bergamo and 9 other locations) |
| Trial ID | NCT04625023 on ClinicalTrials.gov |
What this trial studies
METAMECH is an observational protocol designed to enhance collaboration between basic and clinical research in breast cancer. It will follow a cohort of at least 500 patients over their treatment journey, collecting longitudinal clinical data and samples. The study aims to understand the interactions between tumor and host cells to improve patient outcomes, including reducing recurrence rates and enhancing survival. Patients will be enrolled at two therapeutic checkpoints: before tumor sampling or before starting any treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis or strong suspicion of breast cancer.
Not a fit: Patients with other current malignancies or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for breast cancer patients.
How similar studies have performed: Other studies have shown success in similar collaborative approaches, but this specific protocol is novel in its comprehensive mechanobiology focus.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bergamo, Bergamo and 9 other locations
- Asst Papa Giovanni Xxiii — Bergamo, Bergamo, Italy (Not_yet_recruiting)
- Fondazione IRCCS, Istituto Nazionale dei Tumori — Milan, Milan, Italy (Recruiting)
- Fondazione IRCCS, Istituto Neurologico Carlo Besta — Milan, Milan, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Maggiore della Carità di Novara — Novara, Novara, Italy (Recruiting)
- Istituto Oncologico Veneto IRCCS (IOV) — Padova, Padova, Italy (Recruiting)
- Fondazione IRCCS, Policlinico San Matteo Pavia — Pavia, Pavia, Italy (Recruiting)
- Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO) — Roma, Roma, Italy (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)
Study contacts
- Study coordinator: Smeralda Rapisarda
- Email: clinical.trials@ifom.eu
- Phone: +3902574303236
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.