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Recruiting NCT07427537

Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients

No phase Interventional Cancer, Lung Colon Neoplasm Neuropathy;Peripheral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of blood concentrations of microRNAs, Chemotherapy-induced peripheral neuropathy (CIPN) - grade, Pain assessement, Assessment of blood concentrations of neurofilament light chain.
Who it may be relevant to
Registry conditions: Cancer, Lung, Colon Neoplasm, Neuropathy;Peripheral. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This study aims to find out whether certain molecules in the blood, called microRNAs, are linked to how often and how severely people develop nerve damage from chemotherapy. The investigators will look at patients receiving cancer drugs known to affect the nerves, such as paclitaxel (used for lung cancer) and oxaliplatin (used for colorectal cancer).

Interventions

  • Diagnostic test Assessment of blood concentrations of microRNAs
    day 1, day 43, and day 155.
  • Other Chemotherapy-induced peripheral neuropathy (CIPN) - grade
    day 1, day 43, and day 155.
  • Other Pain assessement
    day 1, day 43, and day 155.
  • Diagnostic test Assessment of blood concentrations of neurofilament light chain
    day 1, day 43, and day 155.
  • Other Neuropathic pain assessment
    day 1, day 43, and day 155.
  • Other Chemotherapy-induced peripheral neuropathy (CIPN) - severity
    day 1, day 43, and day 155.

Primary outcome measures

  • Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy [Time frame: day 1, day 43, and day 155]
Secondary outcome measures (5)
  • Grade of sensory chemotherapy-induced peripheral neuropathy [Time frame: day 1, day 43, and day 155]
  • Severity score of motor chemotherapy-induced peripheral neuropathy [Time frame: day 1, day 43, and day 155]
  • Pain occurrence and severity [Time frame: day 1, day 43, and day 155]
  • Occurrence of neuropathic pain [Time frame: day 1, day 43, and day 155]
  • Concentrations of neurofilament light chain [Time frame: day 1, day 43, and day 155]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHU Clermont-Ferrand — Clermont-Ferrand

Identifiers

NCT: NCT07427537 · RBHP 2024 BALAYSSAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗