NCT07754513Not yet recruiting
Circulating Tumor Extracellular Vesicles for Non-Invasive Monitoring of Metastatic Colorectal Cancer
Circulating Tumor Extracellular Vesicles As Novel Non-invasive Biomarkers to Monitor Metastatic Colorectal Cancer Transcriptomic and Proteomic Evolution
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 290 (estimated)
- First submitted
- 4 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2029
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Colorectal cancer
- NCT number
- NCT07754513
What you commit to
- Study type: Observational
- Planned participants: 290
- From 1 Sept 2026 to the primary completion date, 1 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Retrospective Cohort Inclusion Criteria:
- 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;
- Availability of stored biological samples collected at least at one of the protocol-defined time points (baseline, post-treatment, disease progression);
- Informed consent acquisition will be performed in accordance with Article 110-bis of the Italian Privacy Code.
- Retrospective Cohort Exclusion Criteria:
- 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.
- Prospective Cohort Inclusion Criteria:
- Age ≥ 18 years;
- Histologically confirmed diagnosis of colorectal adenocarcinoma;
- Radiological evidence of unresectable metastatic disease;
- Patients not previously treated for metastatic disease (prior completed adjuvant/neoadjuvant therapy is allowed if completed ≥ 6 months before study enrollment);
- Indication for first-line treatment with chemotherapy ± biological therapy according to standard clinical practice;
- Ability to understand the study procedures and provide written informed consent.
- Prospective Cohort Exclusion Criteria:
- Previous systemic treatment for metastatic disease (except prior adjuvant/neoadjuvant therapy as specified above);
- Ongoing pregnancy or breastfeeding;
- Legal incapacity or limitation in the ability to provide informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.