A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)
NCT ID: NCT05101382
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2020-10-28
2026-12-31
Brief Summary
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Detailed Description
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The repository will feed experimental precision research aimed at i) defining a new taxonomy of CRC based on evolutionary patterns (retrospectively assessed on patient's samples), ii) developing and evaluating innovative biomarker-specific therapeutic strategies derived from or together with ALFAOMEGA.
The following data and biological samples will be collected:
* Clinical Data (Demographics, Medical History, Cancer Diagnosis \& History, Treatment Assessment,).
* Imaging Data (CT-Scans, MRI, PET...).
* Formalin-Fixed Paraffin-Embedded (FFPE) tissue (either from surgical resections or diagnostic biopsies).
* Frozen biological samples (blood, plasma, PBMC, stools, buccal swabs, urines, etc.).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort of CRC patients
Stage-mixed cohort of at least 500 CRC patients that cannot be reached for informed consent (death or lost-to-follow-up)
Observation
Retrospective Observation of standard clinical practice
Interventions
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Observation
Retrospective Observation of standard clinical practice
Eligibility Criteria
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Inclusion Criteria
* Age \>18 years at the time of diagnosis.
* Availability of clinically-annotated radio-imaging data and/or diagnostic Formalin-Fixed Paraffin Embedded (FFPE) blocks (surgical resections and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides.
* Verification that the patient could not be reached for informed consent in accordance with applicable national regulations.
18 Years
ALL
No
Sponsors
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IFOM ETS - The AIRC Institute of Molecular Oncology
OTHER
Responsible Party
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Principal Investigators
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Silvia Marsoni, MD
Role: STUDY_DIRECTOR
IFOM ETS - The AIRC Institute of Molecular Oncology
Locations
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Ospedale Policlinico San Martino
Genova, GE, Italy
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan, MI, Italy
Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy
IRCCS Istituto Clinico Humanitas
Milan, MI, Italy
Istituto Oncologico Veneto (IOV)
Padua, PD, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Pisa, Italy
Istituto di Candiolo - IRCCS
Candiolo, TO, Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, TO, Italy
Azienda Ospedaliera Ordine Mauriziano
Torino, TO, Italy
Institut Català D'Oncologia (ICO)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital del Mar - Parc de Salut Mar
Barcelona, , Spain
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, , Spain
INCLIVA - Instituto de Investigatión Sanitaria
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Stefania Sciallero, MD
Role: primary
Filippo Pietrantonio, MD
Role: primary
Emanuela Bonoldi, MD
Role: primary
Sara Lonardi, MD
Role: primary
Caterina Marchiò, MD
Role: primary
Maurizio Degiuli, MD
Role: primary
Clara Montagut, MD
Role: primary
Elena Élez, MD
Role: primary
Andres Cervantes, MD
Role: primary
Other Identifiers
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IFOM-CPO006/2019/PO005
Identifier Type: -
Identifier Source: org_study_id
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