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Observational study of colorectal cancer patient outcomes

A Master Protocol Empowering Precision Research in Colorectal Cancer

IFOM ETS - The AIRC Institute of Molecular Oncology · NCT04120935

This study is trying to understand how colorectal cancer and the body work together over time to find better treatment options for patients who haven't had therapy before.

Quick facts

Study typeObservational
Enrollment3000 (estimated)
Ages18 Years and up
SexAll
SponsorIFOM ETS - The AIRC Institute of Molecular Oncology (other)
Locations19 sites (Biella, Biella and 18 other locations)
Trial IDNCT04120935 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis or strong suspicion of colorectal cancer and available diagnostic tissue samples.

Not a fit: Patients with other current malignancies or those unable to comply with the study protocol due to psychological, social, or geographical reasons may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and reduced recurrence in colorectal cancer patients.

How similar studies have performed: Other studies focusing on the evolutionary mechanisms of tumors have shown promise, suggesting that this approach could yield valuable insights.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Biella, Biella and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Colorectal Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.