Status:
RECRUITING
ALFAOMEGA Master Observational Trial
Lead Sponsor:
IFOM ETS - The AIRC Institute of Molecular Oncology
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
AlfaOmega has been designed to streamline the study of the co-evolutionary landscape between tumor and host cells in a cohort of CRC patients, with the aim of understanding how their outcomes can be s...
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 longitudina...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04120935
Start Date
October 15 2019
End Date
December 1 2026
Last Update
August 24 2025
Active Locations (19)
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1
ASL di Biella - Ospedale degli Infermi
Biella, Biella, Italy, 13875
2
IRCCS Istituto Clinico Humanitas
Milan, MI, Italy, 20089
3
Fondazione IRCCS, Istituto Nazionale dei Tumori
Milan, MI, Italy, 20133
4
Istituto Europeo di Oncologia (IEO)
Milan, Mi, Italy, 20141