Cancer, LungmiR-CIPN#1NCT07427537
Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients
A study testing Assessment of blood concentrations of microRNAs, Chemotherapy-induced peripheral neuropathy (CIPN) - grade and Pain assessement in people with Cancer, Lung and Colon Neoplasm, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Lung, Colon Neoplasm, Neuropathy;Peripheral
- What is being tested?
- Assessment of blood concentrations of microRNAs, Chemotherapy-induced peripheral neuropathy (CIPN) - grade and Pain assessement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Lise LACLAUTRE, 0473754963, llaclautre_perrier@chu-clermontferrand.fr
David BALAYSSAC
About this study
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).
- Conditions
- Cancer, Lung, Colon Neoplasm, Neuropathy;Peripheral
- Being tested
- Assessment of blood concentrations of microRNAs, Chemotherapy-induced peripheral neuropathy (CIPN) - grade, Pain assessement, Assessment of blood concentrations of neurofilament light chain, Neuropathic pain assessment
- Keywords
- biomarker, colorectal cancer, lung cancer, oxaliplatin, paclitaxel, chemotherapy-induced peripheral neuropathy
- Medical subject headings
- Lung Neoplasms, Colonic Neoplasms, Neuritis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of blood concentrations of microRNAsDiagnostic test
Also called MicroRNAs measured in patients' plasma.
day 1, day 43, and day 155.
Chemotherapy-induced peripheral neuropathy (CIPN) - gradeOther
Also called CIPN grade monitored using the National Cancer Institute - Common Terminology Criteria for Adverse Events.
day 1, day 43, and day 155.
Pain assessementOther
Also called Pain assessment done with a numeric rating scale (scores from 0 (best) to 10 (worst)).
day 1, day 43, and day 155.
Assessment of blood concentrations of neurofilament light chainDiagnostic test
Also called Neurofilament light chain will measured in patients' plasma.
day 1, day 43, and day 155.
Neuropathic pain assessmentOther
Also called 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.
day 1, day 43, and day 155.
Chemotherapy-induced peripheral neuropathy (CIPN) - severityOther
Also called CIPN severity assessed with the self-administered questionnaire QLQ-CIPN20 (scores from 0 (best) to 100 (worst)).
day 1, day 43, and day 155.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel group | Experimental | Patients suffering from lung cancer and treated with paclitaxel Receives: 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 |
| Oxaliplatin group | Experimental | Patients suffering from colorectal cancer and treated with oxaliplatin Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1, day 43, and day 155
Secondary outcomes (5)
Grade of sensory chemotherapy-induced peripheral neuropathy
The grade of sensory chemotherapy-induced peripheral neuropathy will be assessed using the NCI-CTCAE v6.
Measured: day 1, day 43, and day 155
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
Measured: day 1, day 43, and day 155
Pain occurrence and severity
Pain will be assessed using a numerical rating scale (0-10).
Measured: day 1, day 43, and day 155
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.
Measured: day 1, day 43, and day 155
Concentrations of neurofilament light chain
The concentration of neurofilament light chain will be assessed in plasma.
Measured: day 1, day 43, and day 155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start29 Jan 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, LungStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David BALAYSSAC, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427537
- Sponsor's protocol ID
- RBHP 2024 BALAYSSAC
- Acronym
- miR-CIPN#1
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to French regulations, the data cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients
- ClinicalTrials.gov ID
- NCT07427537
- Acronym / sponsor ID
- miR-CIPN#1 / RBHP 2024 BALAYSSAC
- Conditions
- Cancer, Lung, Colon Neoplasm, Neuropathy;Peripheral
- Keywords
- biomarker, colorectal cancer, lung cancer, oxaliplatin, paclitaxel, chemotherapy-induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel group | Experimental | 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) - severityPatients suffering from lung cancer and treated with paclitaxel |
| Oxaliplatin group | Experimental | 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) - severityPatients suffering from colorectal cancer and treated with oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of blood concentrations of microRNAsAlso: MicroRNAs measured in patients' plasma.day 1, day 43, and day 155. | Diagnostic test | Oxaliplatin group, Paclitaxel group |
| Chemotherapy-induced peripheral neuropathy (CIPN) - gradeAlso: CIPN grade monitored using the National Cancer Institute - Common Terminology Criteria for Adverse Events.day 1, day 43, and day 155. | Other | Oxaliplatin group, Paclitaxel group |
| Pain assessementAlso: Pain assessment done with a numeric rating scale (scores from 0 (best) to 10 (worst)).day 1, day 43, and day 155. | Other | Oxaliplatin group, Paclitaxel group |
| Assessment of blood concentrations of neurofilament light chainAlso: Neurofilament light chain will measured in patients' plasma.day 1, day 43, and day 155. | Diagnostic test | Oxaliplatin group, Paclitaxel group |
| Neuropathic pain assessmentAlso: 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.day 1, day 43, and day 155. | Other | Oxaliplatin group, Paclitaxel group |
| Chemotherapy-induced peripheral neuropathy (CIPN) - severityAlso: CIPN severity assessed with the self-administered questionnaire QLQ-CIPN20 (scores from 0 (best) to 100 (worst)).day 1, day 43, and day 155. | Other | Oxaliplatin group, Paclitaxel group |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. Due to French regulations, the data cannot be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David BALAYSSAC principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of blood concentrations of microRNAs, Chemotherapy-induced peripheral neuropathy (CIPN) - grade and Pain assessement in people with Cancer, Lung and Colon Neoplasm, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood concentrations of microRNAs and severity score of sensory chemotherapy-induced peripheral neuropathy (time frame: day 1, day 43, and day 155). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.