Circulating Tumor Extracellular Vesicles for Non-Invasive Monitoring of Metastatic Colorectal Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

Metastatic colorectal cancer (mCRC) remains a major clinical challenge due to heterogeneous treatment responses and the development of therapeutic resistance. Current tissue-based molecular profiling is limited by invasiveness and the inability to enable longitudinal monitoring. Extracellular vesicles (EVs) represent a promising source of non-invasive biomarkers, carrying stable RNA and proteins reflective of tumor biology. This study aims to identify and validate EV-derived transcriptomic and proteomic biomarkers to monitor disease evolution, predict treatment response, and support personalized management of patients with mCRC.

Eligibility criteria

Qualifiers

Age ≥ 18 years;

Histologically confirmed diagnosis of colorectal adenocarcinoma;

Radiological evidence of metastatic or locally advanced unresectable disease;

First-line treatment for metastatic disease already completed or ongoing according to standard clinical practice;

Disqualifiers

Absence of suitable biological samples or samples unsuitable for molecular analyses;

Incomplete clinical data preventing the performance of the planned analyses;

Insufficient quality of stored biological samples for the assessment of EV-RNA and EV-PROT analyses.

Age ≥ 18 years;

Trial design

Treatments tested in this trial

  • Blood sample

Treatment groups

290 Participants
are divided into 2 treatment groups

Locations

This trial has no locations