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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07754513
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood sample — OTHER
    Collection, in conjunction with blood sampling performed as part of routine clinical practice, of a 9 mL blood sample in an EDTA tube at the following time points: before treatment initiation, at the first radiological reassessment, and at disease progression. This sample collection is part of the standard clinical management of patients with metastatic colorectal cancer (mCRC).

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
290 participants (estimated)

Arms

  • Arm: Retrospective cohort
    The retrospective cohort will include 160 patients with metastatic colorectal cancer (mCRC) who have previously received first-line systemic therapy (chemotherapy with or without targeted biological agents). Biological samples and corresponding clinical data, collected as part of routine clinical practice between 2017 and 2025, will be retrospectively analyzed.
  • Arm: Prospective cohort
    The prospective cohort will include 130 treatment-naïve patients with metastatic colorectal cancer (mCRC) who will be prospectively enrolled at the start of first-line systemic therapy for longitudinal collection of biological samples and clinical data.

Primary Outcome Measure

Identification and Validation of Extracellular Vesicle-Derived Biomarkers in Metastatic Colorectal Cancer [ Time Frame: 3 years ]

Central Contacts

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