Blood microRNA markers for chemotherapy-related peripheral nerve damage in lung and colorectal cancer
Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients
This study will test whether levels of tiny blood molecules called microRNAs can predict how often and how badly patients with lung or colorectal cancer get nerve damage from certain chemotherapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT07427537 on ClinicalTrials.gov |
What this trial studies
Patients starting oxaliplatin-based adjuvant chemotherapy for colorectal cancer or paclitaxel-based chemotherapy for lung cancer will be enrolled and followed through their treatment cycles. Blood samples will be taken to measure circulating microRNAs and neurofilament light chain, while clinicians record CIPN grades, QLQ-CIPN20 scores, and neuropathic pain ratings at baseline and during treatment. Investigators will compare molecular marker levels with the timing and severity of chemotherapy-induced peripheral neuropathy to look for predictive patterns. Key exclusions include pre-existing neuropathy, neurodegenerative disease, recent stroke, high baseline pain, pregnancy, or legal protection status to reduce confounding and protect vulnerable participants.
Who should consider this trial
Good fit: Ideal candidates are adults treated for colorectal cancer scheduled for at least six cycles of oxaliplatin or adults treated for lung cancer scheduled for at least four cycles of paclitaxel, without pre-existing neuropathy, major neurodegenerative disease, high baseline pain, or pregnancy.
Not a fit: Patients with pre-existing neuropathy, significant baseline pain, neurodegenerative disease, recent stroke, or those not receiving the specified chemotherapy regimens are unlikely to benefit from the study findings.
Why it matters
Potential benefit: If successful, this could help identify patients at high risk of chemo-induced nerve damage earlier so clinicians can adjust treatment or offer protective strategies to reduce long-term neuropathy.
How similar studies have performed: Small prior studies have reported promising links between circulating microRNAs (and other blood markers) and chemotherapy neuropathy, but these findings remain preliminary and are not yet validated for clinical use.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient treated for colorectal cancer and scheduled to receive oxaliplatin-based adjuvant chemotherapy for at least 6 cycles, or * Patient treated for lung cancer and scheduled to receive paclitaxel-based chemotherapy for at least 4 cycles. Exclusion Criteria: * Neurodegenerative disease (e.g., Parkinson's, Alzheimer's, etc.), * History of stroke, * Pre-existing neuropathy (QLQ-CIPN20 sensory score ≥ 15/100), * Pain (NRS ≥ 4/10), * Pregnant or breastfeeding women, * Patients under guardianship, curatorship, deprived of liberty, or under legal protection
Where this trial is running
Clermont-Ferrand
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: David BALAYSSAC — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.