Prospective Exploratory Study of a Multiomic Blood Biomarker Panel to Predict Chemotherapy-Induced Peripheral Neuropathy (CIPN)

NCT07511569 | Not Yet Recruiting DMC

• 1 other identifier: 2026-001
• Study Type: observational
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this prospective, multicenter, observational cohort study with longitudinal blood sampling and standardized neurological evaluation over 6 months is to identify biomarkers to predict the overall occurrence of chronic chemotherapy-induced peripheral neuropathy (CIPN, any grade), in each of two treatment subgroups (taxanes and oxaliplatin). It involves integration of clinical data and plasma multiomic biomarkers (proteomic + metabolomic panel) analyzed via supervised machine learning to identify predictive features of CIPN.

Conditions

Chemotherapy Induced Neuropathic Pain; Neuropathy Toxic; Taxane-induced Peripheral Neuropathy; Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Neuropathy prediction

  1\. To predict the occurrence of severe CIPN defined as grade 3 chronic neuropathy measured with appropriate tool (cf related section), in each of the two treatment subgroups (taxanes and oxaliplatin).

  From enrollment to 6 months after.

Secondary Outcomes (2)

• Neuropathy severity prediction

  From enrollment to 6 months after

• Time to onset of chronic neuropathy

  from enrollment to 6 months after

Interventions

longitudinal blood sampling and standardized neurological evaluation over 6 months DIAGNOSTIC_TEST

Prospective, multicenter, observational cohort study with longitudinal blood sampling and standardized neurological evaluation over 6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We plan to recruit 192 consecutive patients undergoing cancer treatment with neurotoxic drug (either taxanes - paclitaxel or docetaxel- or platinum-based agent (oxaliplatin), for a treatment duration of at least nine weeks.

You may qualify if:

• Patients who have received detailed information about the study and have signed, with the investigator, a consent form to participate in the study
• Patients being treated for cancer at any stage of the disease and scheduled to receive chemotherapy including one (and only one) of the following molecules: paclitaxel, docetaxel, or oxaliplatin, for a planned duration of 9 weeks or more
• Age \> 18 years
• Life expectancy \> 3 months
• Patient affiliated with or entitled to social security

You may not qualify if:

• Patients already suffering from neuropathy or chronic neurogenic pain
• Patients with type 1 or type 2 diabetes (for more than 10 years for type 2 diabetes)
• Patients who have already received neurotoxic cancer treatment including those in clinical trials
• Patients receiving two of the study molecules simultaneously (only one study molecule is permitted, including in combination chemotherapy but that does not include another neurotoxic molecule)
• Patients receiving immunotherapy

Sponsors & Collaborators

• Centre Hospitalier de Bligny: lead
• Hopital Forcilles: collaborator
• AgenT: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

4 ml of total blood will be collected for exploratory markers analysis. * Performed before the start of treatment at Visit 1 and at the 4 follow-up visits (Visits 2, 3, 4 and 5) and optional sampling if neuropathy occurs lately. * Use of K2-EDTA tubes with inversion mixing (10 times). * Centrifugation at 2,000g, without brake, at 4°C within 3 hours of collection. * Plasma stored at -80°C after aliquoting: * 2 x 30 µL for protein assays. * 2 x 120 µL for metabolites. * 2 x 250 µL for potential additional markers (Nfl as an example) * The rest (approximately 2 aliquots of 350 µL) in reserve.

Central Study Contacts

Jean-Baptiste Méric, MD

CONTACT

33+686961024; jb.meric@chbligny.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): June 4, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04