ALFAOMEGA Master Observational Trial
Recruiting · NCT04120935 · Observational (researchers observe without assigning treatment) · Lead sponsor: IFOM ETS - The AIRC Institute of Molecular Oncology
View the official record on ClinicalTrials.gov →Interventions studied
Observation
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
19 locations listed.
- Hospital Moises Broggi - Barcelona, Spain
- Ospedale Policlinico San Martino - Genova, Italy
- Azienda Ospedaliera Universitaria Luigi Vanvitelli - Naples, Italy
- Azienda Ospedaliera Ordine Mauriziano - Torino, Italy
- Hospital de Sant Joan Despí Moises Broggi - Barcelona, Barcelona, Spain
- ASL di Biella - Ospedale degli Infermi - Biella, Biella, Italy
- IRCCS Istituto Clinico Humanitas - Milan, MI, Italy
- Fondazione IRCCS, Istituto Nazionale dei Tumori - Milan, MI, Italy
- Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda - Milan, MI, Italy
- Istituto Europeo di Oncologia (IEO) - Milan, Mi, Italy
- Istituto Oncologico Veneto (IOV) - Padova, PD, Italy
- Ospedale Santa Maria della Misericordia - Perugia, Perugia, Italy
- Azienda Ospedaliero Universitaria Pisana - Pisa, Pisa, Italy
- AUSL della Romagna - Ospedale Santa Maria delle Croci - Ravenna, Ravenna, Italy
- Hospital del Mar - Parc de Salut Mar - Barcelona, Spain, Spain
- Vall d'Hebron Institute of Oncology (VHIO) - Barcelona, Spain, Spain
- INCLIVA - Instituto de Investigatión Sanitaria - Valencia, Spain, Spain
- Istituto di Candiolo - IRCCS - Candiolo, Torino, Italy
- Azienda Ospedaliero Universitaria San Luigi Gonzaga - Orbassano, Torino, Italy