A Retrospective Protocol Empowering Precision Research in Colorectal Cancer (ALFAOMEGA-RETRÒ)

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

About this trial

ALFAOMEGA-RETRÒ will be exploited to retrospectively collect clinical and imaging data and archival samples to be used for validation and correlative studies on markers discovered by cutting-edge translational projects within the AIRC5x1000 program "Insights into the evolving heterogeneity of colorectal cancer (CRC): from mechanism to therapies" (an ongoing multi-institutional research program).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically-confirmed diagnosis of colorectal cancer (any stage).

Age >18 years at the time of diagnosis.

Availability of clinically-annotated radio-imaging data and/or diagnostic Formalin-Fixed Paraffin Embedded (FFPE) blocks (surgical resections and/or tumor biopsies), or at least 10 slides (preferably 20). FFPE tissue blocks are always preferred to slides.

Verification that the patient could not be reached for informed consent in accordance with applicable national regulations.

Disqualifiers

if inclusion criteria are not met

Trial population

at least 500 colorectal cancer patients at any stage who cannot be reached for an informed consent

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Observation

    Other intervention

    Retrospective Observation of standard clinical practice

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Cohort of CRC patients1 intervention

Trial outcomes

Primary outcomes

1

Number of retrospectively recruited CRC cases

Number of retrospectively recruited CRC cases with complete matched clinical data, radio-imaging data and FFPE or frozen biological samples.

Time frame
6 months

Secondary outcomes

Other outcomes

1

Number of new prognostic and predictive markers

Number of identified/validated new independent prognostic and predictive biomarkers

Time frame
6 months
2

Biomarkers correlation with PFS

Correlation of new prognostic and predictive biomarkers with progression-free survival (PFS).

Time frame
6 months
3

Biomarkers correlation with OS

Correlation of new prognostic and predictive biomarkers with overall survival (OS).

Time frame
6 months

Sponsors and contacts

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