- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04120935
ALFAOMEGA Master Observational Trial (ALFAOMEGA)
A Master Protocol Empowering Precision Research in Colorectal Cancer
Study Overview
Detailed Description
AlfaOmega is an observational study that 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, AlphaOmega will also allow to develop companion diagnostics for molecular enrichment strategies in AIRC-driven proof-of-concept trials. To achieve the required level of 'experimental precision', patients will enter AlphaOmega at two different 'therapeutic checkpoints': i) prior to a surgical event or ii) prior to a systemic treatment. In the latter case patients with no previous lines of therapy for metastatic disease will be privileged.
To optimize the enrollment of patients, the longitudinal collection of data/samples and their logistic management, AlphaOmega has been designed as a flexible infrastructure organized in TIERS for the stepwise comprehension of the biological processes that drive tumor evolution, and precisely:
- TIER1, Monitoring: the ability to follow CRC evolution under standard of care treatments and to define new evolution-linked biomarkers. This will be achieved through the collection of clinical data, imaging data, FFPE tissue and frozen plasma/PBMC.
- TIER2, Modelling: the ability to develop pertinent experimental models to study evolutionary mechanisms and define evolution-targeting therapeutic strategies. This will be achieved through the collection of Fresh Tissue, Whole Blood, Stools, Buccal Swabs and other fluids.
- TIER3, Linking: the ability to access data and samples of patients enrolled in proof-of-concept trials to prove the efficacy and study/understand resistance mechanisms of evolution-targeting therapies. This will be achieved by introducing the connection in the trial protocol.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Luca Lazzari, PhD
- Phone Number: +3902574303799
- Email: clinical.trials@ifom.eu
Study Contact Backup
- Name: Paolo Luraghi, PhD
- Phone Number: +3902574303799
- Email: clinical.trials@ifom.eu
Study Locations
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Biella, Italy, 13875
- Recruiting
- ASL di Biella - Ospedale degli Infermi
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Contact:
- Francesco Leone, MD
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Genova, Italy
- Recruiting
- Ospedale Policlinico San Martino
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Contact:
- Stefania Sciallero, MD
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Perugia, Italy, 06129
- Recruiting
- Ospedale Santa Maria della Misericordia
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Contact:
- Mario Mandalà, MD
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Pisa, Italy, 56126
- Recruiting
- Azienda Ospedaliero Universitaria Pisana
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Contact:
- Chiara Cremolini, MD
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Ravenna, Italy, 48121
- Recruiting
- AUSL della Romagna - Ospedale Santa Maria delle Croci
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Contact:
- Stefano Tamberi, MD
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Torino, Italy
- Active, not recruiting
- Azienda Ospedaliera Ordine Mauriziano
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MI
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Milan, MI, Italy, 20133
- Recruiting
- Fondazione IRCCS, Istituto Nazionale dei Tumori
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Contact:
- Filippo Pietrantonio, MD
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Milan, MI, Italy, 20162
- Recruiting
- Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda
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Contact:
- Salvatore Siena, MD
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Mi
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Milan, Mi, Italy, 20141
- Recruiting
- Istituto Europeo di Oncologia (IEO)
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Contact:
- Maria Giulia Zampino, MD
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PD
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Padova, PD, Italy, 35128
- Recruiting
- Istituto Oncologico Veneto (IOV)
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Contact:
- Sara Lonardi, MD
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Torino
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Candiolo, Torino, Italy, 10060
- Recruiting
- Istituto di Candiolo - IRCCS
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Contact:
- Elisabetta Fenocchio, MD
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Orbassano, Torino, Italy
- Recruiting
- Azienda Ospedaliero Universitaria San Luigi Gonzaga
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Contact:
- Maurizio Degiuli, MD
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-
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Barcelona, Spain, 08035
- Recruiting
- Vall d'Hebron Institute of Oncology (VHIO)
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Contact:
- Josep Tabernero, MD
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Barcelona, Spain, 08970
- Recruiting
- Hospital de Sant Joan Despí Moisès Broggi
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Contact:
- Cristina Vivas, MD
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Barcelona, Spain, 08003
- Recruiting
- Hospital del Mar - Parc de Salut Mar
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Contact:
- Clara Montagut, MD
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Valencia, Spain, 46010
- Recruiting
- INCLIVA - Instituto de Investigatión Sanitaria
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Contact:
- Andrés Cervantes, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- TIER1 written Informed consent.
- Patients ≥18 years of age.
- Previous diagnosis of colorectal cancer, or a strong suspicion of CRC based on clinical and radiological findings.
- In patients with previous diagnosis of CRC availability of diagnostic Formalin-Fixed, Paraffin Embedded (FFPE) blocks (surgical resection and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides.
- ECOG Performance status < 2.
Exclusion Criteria:
- 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)
- Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.
- Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cohort of CRC patients
Stage-mixed cohort of at least 500 patients through their course of treatments, until death or a minimum of 5 years.
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Prospective Observation of standard clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients longitudinally monitored
Time Frame: 6 months
|
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients triaged in proof-of-concept (POC) clinical trials
Time Frame: 6 months
|
Number of CRC cases recruited in TIER3.
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6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of new prognostic and predictive biomarkers
Time Frame: 6 months
|
|
6 months
|
Correlation of new prognostic and predictive biomarkers with clinical outcomes
Time Frame: 6 months
|
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Silvia Marsoni, MD, IFOM ETS - The AIRC Institute of Molecular Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFOM-CPO003/2018/PO002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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