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Recruiting NCT04120935

NCT04120935 ALFAOMEGA Master Observational Trial

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Clinical Trial Summary
NCT ID NCT04120935
Status Recruiting
Phase
Sponsor IFOM ETS - The AIRC Institute of Molecular Oncology
Condition Colorectal Cancer
Study Type OBSERVATIONAL
Enrollment 3,000 participants
Start Date 2019-10-15
Primary Completion 2026-06

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Observation

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 3,000 participants in total. It began in 2019-10-15 with a primary completion date of 2026-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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 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 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.

Contact & Investigator

Central Contact

Luca Lazzari, PhD

✉ clinical.trials@ifom.eu

📞 +3902574303799

Principal Investigator

Silvia Marsoni, MD

PRINCIPAL INVESTIGATOR

IFOM ETS - The AIRC Institute of Molecular Oncology

Frequently Asked Questions

Who can join the NCT04120935 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04120935 currently recruiting?

Yes, NCT04120935 is actively recruiting participants. Contact the research team at clinical.trials@ifom.eu for enrollment information.

Where is the NCT04120935 trial being conducted?

This trial is being conducted at Biella, Italy, Milan, Italy, Milan, Italy, Milan, Italy and 11 additional locations.

Who is sponsoring the NCT04120935 clinical trial?

NCT04120935 is sponsored by IFOM ETS - The AIRC Institute of Molecular Oncology. The principal investigator is Silvia Marsoni, MD at IFOM ETS - The AIRC Institute of Molecular Oncology. The trial plans to enroll 3,000 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology