Circulating Tumor Extracellular Vesicles for Non-Invasive Monitoring of Metastatic Colorectal Cancer (NCT07754513) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Circulating Tumor Extracellular Vesicles for Non-Invasive Monitoring of Metastatic Colorectal Cancer
290 participantsStarted 2026-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Pre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification and Validation of Extracellular Vesicle-Derived Biomarkers in Metastatic Colorectal Cancer