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

NCT07754513 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 290

Last updated 2026-08-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Blood sample

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).

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Donatella Lucchetti, PhD · Catholic University of the Sacred Heart

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-09-01
Completion
2029-09-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754513 on ClinicalTrials.gov