Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients (miR-CIPN#1)

February 16, 2026 updated by: University Hospital, Clermont-Ferrand
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel group
Patients suffering from lung cancer and treated with paclitaxel
Diagnostic test: Assessment of blood concentrations of microRNAs
day 1, day 43, and day 155.
Other Names:
  • MicroRNAs measured in patients' plasma.
Other: Chemotherapy-induced peripheral neuropathy (CIPN) - grade
day 1, day 43, and day 155.
Other Names:
  • CIPN grade monitored using the National Cancer Institute - Common Terminology Criteria for Adverse Events.
Other: Pain assessement
day 1, day 43, and day 155.
Other Names:
  • Pain assessment done with a numeric rating scale (scores from 0 (best) to 10 (worst)).
Diagnostic test: Assessment of blood concentrations of neurofilament light chain
day 1, day 43, and day 155.
Other Names:
  • Neurofilament light chain will measured in patients' plasma.
Other: Neuropathic pain assessment
day 1, day 43, and day 155.
Other Names:
  • Neuropathic pain assessed with the DN4 questionnaire, scores from 0 (best) to 7 (worst), and with a cut-off of 3 on 7 for neuropathic pain screening.
Other: Chemotherapy-induced peripheral neuropathy (CIPN) - severity
day 1, day 43, and day 155.
Other Names:
  • CIPN severity assessed with the self-administered questionnaire QLQ-CIPN20 (scores from 0 (best) to 100 (worst)).
Experimental: Oxaliplatin group
Patients suffering from colorectal cancer and treated with oxaliplatin
Diagnostic test: Assessment of blood concentrations of microRNAs
day 1, day 43, and day 155.
Other Names:
  • MicroRNAs measured in patients' plasma.
Other: Chemotherapy-induced peripheral neuropathy (CIPN) - grade
day 1, day 43, and day 155.
Other Names:
  • CIPN grade monitored using the National Cancer Institute - Common Terminology Criteria for Adverse Events.
Other: Pain assessement
day 1, day 43, and day 155.
Other Names:
  • Pain assessment done with a numeric rating scale (scores from 0 (best) to 10 (worst)).
Diagnostic test: Assessment of blood concentrations of neurofilament light chain
day 1, day 43, and day 155.
Other Names:
  • Neurofilament light chain will measured in patients' plasma.
Other: Neuropathic pain assessment
day 1, day 43, and day 155.
Other Names:
  • Neuropathic pain assessed with the DN4 questionnaire, scores from 0 (best) to 7 (worst), and with a cut-off of 3 on 7 for neuropathic pain screening.
Other: Chemotherapy-induced peripheral neuropathy (CIPN) - severity
day 1, day 43, and day 155.
Other Names:
  • CIPN severity assessed with the self-administered questionnaire QLQ-CIPN20 (scores from 0 (best) to 100 (worst)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy
Time Frame: day 1, day 43, and day 155
Concentrations of microRNAs will be assessed in plasma, and severity score of sensory chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire.
day 1, day 43, and day 155

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grade of sensory chemotherapy-induced peripheral neuropathy
Time Frame: day 1, day 43, and day 155
The grade of sensory chemotherapy-induced peripheral neuropathy will be assessed using the NCI-CTCAE v6.
day 1, day 43, and day 155
Severity score of motor chemotherapy-induced peripheral neuropathy
Time Frame: day 1, day 43, and day 155
The severity score of motor chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire
day 1, day 43, and day 155
Pain occurrence and severity
Time Frame: day 1, day 43, and day 155
Pain will be assessed using a numerical rating scale (0-10).
day 1, day 43, and day 155
Occurrence of neuropathic pain
Time Frame: day 1, day 43, and day 155
Neuropathic pain will be assessed in patients reporting pain with a numerical rating scale (NRS) score of 4 or higher out of 10, and a DN4 questionnaire (short form) score of 3 or higher out of 7.
day 1, day 43, and day 155
Concentrations of neurofilament light chain
Time Frame: day 1, day 43, and day 155
The concentration of neurofilament light chain will be assessed in plasma.
day 1, day 43, and day 155

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: David BALAYSSAC, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2024 BALAYSSAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to French regulations, the data cannot be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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