Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07427537

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer, Lung Colon Neoplasm Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuritis Neuromuscular Diseases Neuropathy;Peripheral Peripheral Nervous System Diseases Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

David BALAYSSAC

PRINCIPAL_INVESTIGATOR

Lise LACLAUTRE

CONTACT

[email protected]

0473754963

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of blood concentrations of microRNAs

Diagnostic Test

day 1, day 43, and day 155.

Other names: MicroRNAs measured in patients' plasma.

Chemotherapy-induced peripheral neuropathy (CIPN) - grade

Other

day 1, day 43, and day 155.

Other names: CIPN grade monitored using the National Cancer Institute - Common Terminology Criteria for Adverse Events.

Pain assessement

Other

day 1, day 43, and day 155.

Other names: Pain assessment done with a numeric rating scale (scores from 0 (best) to 10 (worst)).

Assessment of blood concentrations of neurofilament light chain

Diagnostic Test

day 1, day 43, and day 155.

Other names: Neurofilament light chain will measured in patients' plasma.

Neuropathic pain assessment

Other

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.

Chemotherapy-induced peripheral neuropathy (CIPN) - severity

Other

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)).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. Pain occurrence and severity

    Time frame: day 1, day 43, and day 155

    Pain will be assessed using a numerical rating scale (0-10).

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: miR-CIPN#1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.