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ALFAOMEGA Master Observational Trial

ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIFOM ETS - The AIRC Institute of Molecular Oncology

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Colorectal cancer patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observation

    Other intervention

    Prospective Observation of standard clinical practice.

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Cohort of CRC patients1 intervention

Trial outcomes

Primary outcomes

1

Number of patients longitudinally monitored

1. \- Number of recruited CRC cases in TIER1 with complete FFPE/clinical data match. 2. \- Number of recruited CRC cases in TIER2.

Time frame
6 months

Secondary outcomes

1

Number of patients triaged in proof-of-concept (POC) clinical trials

Number of CRC cases recruited in TIER3.

Time frame
6 months

Other outcomes

1

Number of new prognostic and predictive biomarkers

1. \- Number of identified/validated new prognostic markers 2. \- Number of identified/validated new predictive markers.

Time frame
6 months
2

Correlation of new prognostic and predictive biomarkers with clinical outcomes

1. \- Correlation between identified biomarkers with therapies response rates (RR). 2. \- Correlation between identified biomarkers with progression-free survival (PFS). 3. \- Correlation between identified biomarkers with overall survival (OS).

Time frame
6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IFOM ETS - The AIRC Institute of Molecular Oncology

Lead sponsor

Source ClinicalTrials.gov
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