AlphaOmega is part of a new class of master protocols that represent a new subset of observational trials designed to empower a bi-directional collaboration between pre-clinical and clinical research, an essential prerequisite to feed and implement precision oncology.
AlphaOmega is a patient-centered translational research platform supporting the AIRC 5×1000 grant "Insights into the evolving heterogeneity in Metastatic colorectal cancer: from mechanisms to therapies".
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: July 2025
The study will enroll at least 500 CRC patients. Patients will be tracked from study entry 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. Derived molecular/biological profiles will be matched with clinical characteristics to identify markers that may have prognostic and/or predictive correlation with clinical progression and individual response to treatment. Via a multi-tiered informed consensus process, AlphaOmega will also allow to develop companion diagnostics for molecular enrichment strategies in experimentally-driven proof-of-concept trials.
- Other: Observation
- Prospective Observation of standard clinical practice.
Arms, Groups and Cohorts
- 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.
Clinical Trial Outcome Measures
- Number of patients longitudinally monitored
- Time Frame: 6 months
- - Number of recruited CRC cases in TIER1 with complete FFPE/clinical data match. - Number of recruited CRC cases in TIER2.
- Number of patients triaged in proof-of-concept (POC) clinical trials
- Time Frame: 6 months
- Number of CRC cases recruited in TIER3.
Participating in This Clinical Trial
1. TIER1 written Informed consent.
2. Patients ≥18 years of age.
3. Previous diagnosis of colorectal cancer, or a strong suspicion of CRC based on clinical and radiological findings.
4. 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.
5. ECOG Performance status < 2.
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
- Lead Sponsor
- IFOM, The FIRC Institute of Molecular Oncology
- Provider of Information About this Clinical Study
- Overall Official(s)
- Silvia Marsoni, MD, Principal Investigator, IFOM- Institute of Molecular Oncology
- Overall Contact(s)
- Paolo Luraghi, PhD, +3902574303799, firstname.lastname@example.org
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