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A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer (METAMECH)

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ClinicalTrials.gov Identifier: NCT04625023
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
IFOM, The FIRC Institute of Molecular Oncology

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.


Condition or disease Intervention/treatment
Breast Cancer Other: Observational

Detailed Description:

METAMECH has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of breast cancer (BC) patients, with the aim of understanding how their outcomes can be significantly improved (e.g. reduction of their chance of recurrence and survival improve). This clinical resource for integrative clinical data and sample collection will allow to generate hypotheses on mechanisms supporting the outgrowth of human metastases, mine for new potentially actionable targets and the selection of appropriate patients for experimentally-driven trials. To achieve the required level of 'experimental precision', patients will enter METAMECH at two different 'therapeutic checkpoints': i) prior to a tumor sampling event (surgery, biopsy) or ii) prior to any line of treatment.

To optimize the enrollment of patients, the longitudinal collection of data/samples and their logistic management, METAMECH has been designed as a flexible infrastructure organized in Tiers for the stepwise comprehension of the biological processes that drive tumor evolution, and precisely:

  • TIER0, Retrieving: the ability to retrospectively retrieve clinically annotated BC archival samples to validate/discover new mechanotransduction-linked biomarkers;
  • TIER1, Recording: the ability to prospectively record BC characteristics under standard of care treatments and to define new mechanotransduction-linked biomarkers;
  • TIER2, Modelling: the ability to develop pertinent experimental models to study the aberrant mechanisms underlying the metastatic outgrowth and define mechanotransduction-targeting therapeutic strategies;
  • TIER3, Linking: the ability to access data and samples of patients enrolled in POC trials to prove the efficacy and study/understand resistance mechanisms of mechanotransduction-targeting therapies.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Other
Official Title: A Master Protocol Empowering Mechanobiology Translation Research in Breast Cancer
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Cohort of BC patients
Stage-mixed cohort of at least 500 breast cancer patients through their course of treatment, until death or a minimum of 5 years.
Other: Observational
Retrospective cohorts and Prospective observation of standard clinical practice




Primary Outcome Measures :
  1. Number of patients recruited in TIER0 and TIER 1 [ Time Frame: 6 months ]
    Number of recruited BC cases in TIER 0 and in TIER 1 with complete clinically annotated FFPE and/or frozen biological samples

  2. Number of patients recruited in TIER2 [ Time Frame: 6 months ]
    Number of recruited BC cases in TIER 2


Secondary Outcome Measures :
  1. Number of patients triaged in proof-of concept (POC) clinical trials [ Time Frame: 6 months ]
    Number of BC cases recruited in TIER 3


Other Outcome Measures:
  1. New prognostic mechanotransduction-linked markers [ Time Frame: 6 months ]
    Number of identified/validated new prognostic mechanotransduction-linked markers

  2. New predictive mechanotransduction-linked markers [ Time Frame: 6 months ]
    Number of identified/validated new predictive mechanotransduction-linked markers

  3. Biomarkers correlation with RR [ Time Frame: 6 months ]
    Correlation between identified biomarkers with therapies response rates (RR)

  4. Biomarkers correlation with PFS [ Time Frame: 6 months ]
    Correlation between identified biomarkers with progression-free survival (PFS)

  5. Biomarkers correlation with OS [ Time Frame: 6 months ]
    Correlation between identified biomarkers with overall survival (OS)


Biospecimen Retention:   Samples With DNA
  • FFPE tissue
  • Fresh Tissue (tumor and normal)
  • Plasma
  • PBMC
  • Whole Blood
  • Stools
  • Buccal Swabs
  • Pleural effusions and ascites


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stage-mixed Breast Cancer (BC) patients
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04625023


Contacts
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Contact: Luca Lazzari, PhD +3902574303799 clinical.trials@ifom.eu
Contact: Florida Voli, PhD +3902574303236 clinical.trials@ifom.eu

Locations
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Italy
Asst Papa Giovanni Xxiii Not yet recruiting
Bergamo, Italy, 24127
Contact: Alberto Zambelli, MD         
Fondazione IRCCS, Istituto Nazionale dei Tumori Not yet recruiting
Milan, Italy, 20133
Contact: Claudio Vernieri, MD         
Fondazione IRCCS, Istituto Neurologico Carlo Besta Active, not recruiting
Milan, Italy, 20133
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara Active, not recruiting
Novara, Italy, 28100
Istituto Oncologico Veneto IRCCS (IOV) Recruiting
Padova, Italy, 35128
Contact: PierFranco Conte, MD         
Fondazione IRCCS, Policlinico San Matteo Pavia Not yet recruiting
Pavia, Italy, 27100
Contact: Paolo Pedrazzoli, MD         
Istituto Nazionale Tumori Regina Elena di Roma - Istituti Fisioterapici Ospitalieri (IFO) Not yet recruiting
Roma, Italy, 00144
Contact: Giovanni Blandino, MD         
Sponsors and Collaborators
IFOM, The FIRC Institute of Molecular Oncology
Investigators
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Study Chair: Silvia Marsoni, MD IFOM- FIRC Institute of Molecular Biology
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Responsible Party: IFOM, The FIRC Institute of Molecular Oncology
ClinicalTrials.gov Identifier: NCT04625023    
Other Study ID Numbers: IFOM-CPO007/2019/PO006
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases