RecruitingNCT04120935

ALFAOMEGA Master Observational Trial

A Master Protocol Empowering Precision Research in Colorectal Cancer


Sponsor

IFOM ETS - The AIRC Institute of Molecular Oncology

Enrollment

3,000 participants

Start Date

Oct 15, 2019

Study Type

OBSERVATIONAL

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria3

  • 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.

Interventions

OTHERObservation

Prospective Observation of standard clinical practice.


Locations(19)

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

Istituto Europeo di Oncologia (IEO)

Milan, Mi, Italy

Niguarda Cancer Center - ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

Istituto Oncologico Veneto (IOV)

Padua, 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

Istituto di Candiolo - IRCCS

Candiolo, Torino, Italy

Azienda Ospedaliero Universitaria San Luigi Gonzaga

Orbassano, Torino, Italy

Ospedale Policlinico San Martino

Genova, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Napoli, Italy

Azienda Ospedaliera Ordine Mauriziano

Torino, Italy

Hospital de Sant Joan Despí Moises Broggi

Barcelona, Barcelona, Spain

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

Hospital Moises Broggi

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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NCT04120935