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RecruitingNCT07427537miR-CIPN#1Updated Feb 23, 2026

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

An interventional study of Assessment of blood concentrations of microRNAs and Chemotherapy-induced peripheral neuropathy (CIPN) - grade in Cancer, Lung, Colon Neoplasm and Neuropathy;Peripheral, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Cancer, Lung
  • Colon Neoplasm
  • Neuropathy;Peripheral

Keywords

  • biomarker
  • colorectal cancer
  • lung cancer
  • oxaliplatin
  • paclitaxel
  • chemotherapy-induced peripheral neuropathy
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In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 90 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient treated for colorectal cancer and scheduled to receive oxaliplatin-based 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Paclitaxel group

    Patients suffering from lung cancer and treated with paclitaxel

    Diagnostic Test: Assessment of blood concentrations of microRNAs · Other: Chemotherapy-induced peripheral neuropathy (CIPN) - grade · Other: Pain assessement · Diagnostic Test: Assessment of blood concentrations of neurofilament light chain · Other: Neuropathic pain assessment · Other: Chemotherapy-induced peripheral neuropathy (CIPN) - severity

  • Experimental
    Oxaliplatin group

    Patients suffering from colorectal cancer and treated with oxaliplatin

    Diagnostic Test: Assessment of blood concentrations of microRNAs · Other: Chemotherapy-induced peripheral neuropathy (CIPN) - grade · Other: Pain assessement · Diagnostic Test: Assessment of blood concentrations of neurofilament light chain · Other: Neuropathic pain assessment · Other: Chemotherapy-induced peripheral neuropathy (CIPN) - severity

Interventions

  • Diagnostic testAssessment of blood concentrations of microRNAs

    day 1, day 43, and day 155.

    Also known as: MicroRNAs measured in patients' plasma.

  • OtherChemotherapy-induced peripheral neuropathy (CIPN) - grade

    day 1, day 43, and day 155.

    Also known as: CIPN grade monitored using the National Cancer Institute - Common Terminology Criteria for Adverse Events.

  • OtherPain assessement

    day 1, day 43, and day 155.

    Also known as: Pain assessment done with a numeric rating scale (scores from 0 (best) to 10 (worst)).

  • Diagnostic testAssessment of blood concentrations of neurofilament light chain

    day 1, day 43, and day 155.

    Also known as: Neurofilament light chain will measured in patients' plasma.

  • OtherNeuropathic pain assessment

    day 1, day 43, and day 155.

    Also known as: 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.

  • OtherChemotherapy-induced peripheral neuropathy (CIPN) - severity

    day 1, day 43, and day 155.

    Also known as: CIPN severity assessed with the self-administered questionnaire QLQ-CIPN20 (scores from 0 (best) to 100 (worst)).

06

What researchers measure

Primary outcomes

  1. Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy

    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.

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

Secondary outcomes

  1. Grade of sensory chemotherapy-induced peripheral neuropathy

    The grade of sensory chemotherapy-induced peripheral neuropathy will be assessed using the NCI-CTCAE v6.

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

  2. Severity score of motor chemotherapy-induced peripheral neuropathy

    The severity score of motor chemotherapy-induced peripheral neuropathy will be assessed using the QLQ-CIPN20 questionnaire

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

  3. Pain occurrence and severity

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

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

  4. Occurrence of neuropathic pain

    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.

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

  5. Concentrations of neurofilament light chain

    The concentration of neurofilament light chain will be assessed in plasma.

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

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No — Due to French regulations, the data cannot be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07427537
Responsible party
Sponsor
First posted
Feb 23, 2026
Start date
Jan 29, 2026
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Feb 23, 2026

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
David BALAYSSAC
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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