Observational study of colorectal cancer patient outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The AlfaOmega observational study aims to investigate the co-evolution of tumor and host cells in colorectal cancer (CRC) patients to improve treatment outcomes. It will follow a cohort of at least 500 patients over a minimum of five years, collecting longitudinal clinical data and biological samples. Patients will be enrolled at two therapeutic checkpoints: before surgery or before systemic treatment, with a focus on those with no prior therapy for metastatic disease. The study will also develop companion diagnostics to enhance treatment strategies based on the biological processes driving tumor evolution.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Where it's running

• ASL di Biella - Ospedale degli Infermi
  Biella, Biella, Italy Recruiting
• IRCCS Istituto Clinico Humanitas
  Milan, Mi, Italy Recruiting
• Fondazione IRCCS, Istituto Nazionale dei Tumori
  Milan, Mi, Italy Recruiting
• Istituto Europeo di Oncologia (IEO)
  Milan, Mi, Italy Recruiting
• Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda
  Milan, Mi, Italy Recruiting
• Istituto Oncologico Veneto (IOV)
  Padova, Pd, Italy Recruiting

Study contacts

• Principal investigator: Silvia Marsoni, MD — IFOM ETS - The AIRC Institute of Molecular Oncology
• Study coordinator: Luca Lazzari, PhD
• Email: clinical.trials@ifom.eu
• Phone: +3902574303799

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.