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Clinical Trials in Spain / NCT04120935
Recruiting Observational

ALFAOMEGA Master Observational Trial

NCT04120935 · tracked via the Priya Life Science Spain tracker
Sponsor
IFOM ETS - The AIRC Institute of Molecular Oncology
Phase
Observational
Started
2019-10-15
Last updated
2025-08-24

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

Observation

Observation: Prospective Observation of standard clinical practice.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of patients longitudinally monitored — 6 months
    1. \- Number of recruited CRC cases in TIER1 with complete FFPE/clinical data match. 2. \- Number of recruited CRC cases in TIER2.

Trial sites (19)

FacilityCityRegionStatus
ASL di Biella - Ospedale degli Infermi Biella Biella Recruiting
IRCCS Istituto Clinico Humanitas Milan MI Recruiting
Fondazione IRCCS, Istituto Nazionale dei Tumori Milan MI Recruiting
Istituto Europeo di Oncologia (IEO) Milan Mi Recruiting
Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda Milan MI Recruiting
Istituto Oncologico Veneto (IOV) Padova PD Recruiting
Ospedale Santa Maria della Misericordia Perugia Perugia Recruiting
Azienda Ospedaliero Universitaria Pisana Pisa Pisa Recruiting
AUSL della Romagna - Ospedale Santa Maria delle Croci Ravenna Ravenna Recruiting
Istituto di Candiolo - IRCCS Candiolo Torino Recruiting
Azienda Ospedaliero Universitaria San Luigi Gonzaga Orbassano Torino Recruiting
Ospedale Policlinico San Martino Genova Italy Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli Naples Italy Recruiting
Azienda Ospedaliera Ordine Mauriziano Torino Italy Active Not Recruiting
Hospital de Sant Joan Despí Moises Broggi Barcelona Barcelona Recruiting
Hospital del Mar - Parc de Salut Mar Barcelona Spain Recruiting
Vall d'Hebron Institute of Oncology (VHIO) Barcelona Spain Recruiting
INCLIVA - Instituto de Investigatión Sanitaria Valencia Spain Recruiting
Hospital Moises Broggi Barcelona Spain Recruiting

More IFOM ETS - The AIRC Institute of Molecular Oncology trials in Spain

A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ) Recruiting
The Sagittarius Trial Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04120935 on ClinicalTrials.gov ↗ ← All trials in Spain