Clinical trial · Observational
A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort of BC patients
- description
- Stage-mixed cohort of at least 1500 breast cancer patients through their course of treatment, until death or a minimum of 5 years.
- interventionNames
- Other: Observational
Primary outcomes (2)
- measure
- Number of patients recruited in TIER0 and TIER 1
- timeFrame
- 6 months
- description
- Number of recruited BC cases in TIER 0 and in TIER 1 with complete clinically annotated FFPE and/or frozen biological samples
- measure
- Number of patients recruited in TIER2
- timeFrame
- 6 months
- description
- Number of recruited BC cases in TIER 2
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available