NCT07427537

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

January 5, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

January 29, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

February 23, 2026

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

January 5, 2026

Last Update Submit

February 16, 2026

Conditions

Cancer, LungColon NeoplasmNeuropathy;Peripheral

Keywords

biomarkercolorectal cancerlung canceroxaliplatinpaclitaxelchemotherapy-induced peripheral neuropathy

Outcome Measures

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.

    day 1, day 43, and day 155

Secondary Outcomes (5)

  • Grade of sensory chemotherapy-induced peripheral neuropathy

    day 1, day 43, and day 155

  • Severity score of motor chemotherapy-induced peripheral neuropathy

    day 1, day 43, and day 155

  • Pain occurrence and severity

    day 1, day 43, and day 155

  • Occurrence of neuropathic pain

    day 1, day 43, and day 155

  • Concentrations of neurofilament light chain

    day 1, day 43, and day 155

Study Arms (2)

Paclitaxel group

EXPERIMENTAL

Patients suffering from lung cancer and treated with paclitaxel

Diagnostic Test: Assessment of blood concentrations of microRNAsOther: Chemotherapy-induced peripheral neuropathy (CIPN) - gradeOther: Pain assessementDiagnostic Test: Assessment of blood concentrations of neurofilament light chainOther: Neuropathic pain assessmentOther: Chemotherapy-induced peripheral neuropathy (CIPN) - severity

Oxaliplatin group

EXPERIMENTAL

Patients suffering from colorectal cancer and treated with oxaliplatin

Diagnostic Test: Assessment of blood concentrations of microRNAsOther: Chemotherapy-induced peripheral neuropathy (CIPN) - gradeOther: Pain assessementDiagnostic Test: Assessment of blood concentrations of neurofilament light chainOther: Neuropathic pain assessmentOther: Chemotherapy-induced peripheral neuropathy (CIPN) - severity

Interventions

Chemotherapy-induced peripheral neuropathy (CIPN) - severityOTHER

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)).
Oxaliplatin groupPaclitaxel group
Assessment of blood concentrations of microRNAsDIAGNOSTIC_TEST

day 1, day 43, and day 155.

Also known as: MicroRNAs measured in patients' plasma.
Oxaliplatin groupPaclitaxel group
Chemotherapy-induced peripheral neuropathy (CIPN) - gradeOTHER

day 1, day 43, and day 155.

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

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)).
Oxaliplatin groupPaclitaxel group
Assessment of blood concentrations of neurofilament light chainDIAGNOSTIC_TEST

day 1, day 43, and day 155.

Also known as: Neurofilament light chain will measured in patients' plasma.
Oxaliplatin groupPaclitaxel group
Neuropathic pain assessmentOTHER

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.
Oxaliplatin groupPaclitaxel group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsColonic NeoplasmsNeuritisColorectal Neoplasms

Interventions

Bestrophins

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Chloride ChannelsIon ChannelsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsEye ProteinsMembrane GlycoproteinsMembrane Proteins

Study Officials

  • David BALAYSSAC

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 23, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

February 23, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Due to French regulations, the data cannot be shared.

Locations

FR(1)