Blood extracellular vesicles to detect chemotherapy-related nerve damage.
Official title: Extracellular Vesicles as Predictive Biomarkers for Chemotherapy-Induced Peripheral Neuropathy
Run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · NCT07558447 · Data updated 2026-11-12
We will test whether tiny blood particles called extracellular vesicles can predict who will develop chemotherapy-induced peripheral neuropathy in adults receiving taxane, platinum, or antimitotic chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Drugs / interventions | enfortumab, chemotherapy |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07558447 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with breast, gastrointestinal, lung, urologic, or head and neck cancers who are scheduled to receive specified taxane, platinum, or antimitotic chemotherapies, who have not been diagnosed with CIPN, and who can give informed consent are ideal candidates.
✕Probably not a fit
Patients who already have a diagnosis of chemotherapy-induced peripheral neuropathy or who have neurodegenerative diseases are excluded and would not benefit from prediction in this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational interventional protocol follows adults with specified cancers from before chemotherapy through six months after treatment to track nerve symptoms and blood extracellular vesicle (EV) signals. Participants provide blood samples prior to starting chemotherapy, at the end of treatment, and six months later for measurement of EV concentration and molecular cargo including lipids and microRNAs. Neuropathy symptoms are recorded with questionnaires and simple non-invasive clinical nerve assessments to relate EV changes to onset and severity of CIPN. The study focuses on patients treated with taxanes, platinum compounds, or antimitotic agents to identify EV features associated with subsequent neurotoxicity.
Why it matters
Potential benefit: If successful, this approach could allow earlier identification of patients at higher risk for CIPN so clinicians can consider treatment adjustments or preventive measures to limit nerve damage.
How similar studies have gone: Changes in EVs have been reported in other neurological conditions, but using EVs specifically to predict CIPN is largely exploratory and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Has signed the informed consent form * Is 18 years of age or older * Is male or female * Has breast cancer and is scheduled to receive paclitaxel, docetaxel, eribulin, capecitabine, or carboplatin as part of standard care * Has gastrointestinal cancer and is scheduled to receive oxaliplatin or capecitabine as part of standard care * Has lung cancer and is scheduled to receive cisplatin, carboplatin, or docetaxel as part of standard care * Has urologic cancer and is scheduled to receive carboplatin, cisplatin, paclitaxel, docetaxel, or enfortumab vedotin as part of standard care * Has head and neck cancer and is scheduled to receive carboplatin, paclitaxel, or cisplatin as part of standard care Exclusion Criteria: * Has already been diagnosed with CIPN * Has a neurodegenerative disease
Where it's running
-
SC Oncologia Medica Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy Recruiting
Study contacts
- Principal investigator: Massimiliano Ruscica, PhD — Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
- Study coordinator: Massimiliano Ruscica, PhD
- Email: massimiliano.ruscica@unimi.it
- Phone: 0039 0250318220
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.