ALFAOMEGA Master Observational Trial
A Master Protocol Empowering Precision Research in Colorectal Cancer
IFOM ETS - The AIRC Institute of Molecular Oncology
3,000 participants
Oct 15, 2019
OBSERVATIONAL
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 significantly improved (e.g. reduction of their chance of recurrence and survival improval). This clinical resource for integrative clinical data and sample collection will allow the molecular story-telling of CRC metastatic spread along time and space and the selection of appropriate patients for experimentally-driven trials.
Eligibility
Inclusion Criteria5
- 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 Criteria3
- 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.
Interventions
Prospective Observation of standard clinical practice.
Locations(19)
View Full Details on ClinicalTrials.gov
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NCT04120935