NCT07511569

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 192 (estimated)
• Sponsor: Centre Hospitalier de Bligny · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

In this prospective exploratory cohort study based on artificial intelligence data analysis, we aim to identify useful markers to predict the occurrence of CIPN in patients receiving taxanes or oxaliplatin to treat their cancers. We plan to recruit 192 consecutive patients from 2 hospitals (Hôpital Forcilles and Centre Hospitalier de Bligny) treated for cancer, aimed to receive a prolonged treatment (9 weeks or more) with a neurotoxic drug: taxanes (subgroup 1: 78 patients), and oxaliplatin (subgroup 2: 114 patients). Study design is built to detect promising markers (including biomarkers from our exclusive panel) possibly linked to neuropathy that could help predict its occurrence and clinically meaningful impact. A balanced selection was made to enable the collection of as much information as possible while limiting the impact on patients. Patients will be included before treatment and follow-up will last 6 months after start of treatment.

Conditions

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

Interventions

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

Timeline

• Start date: 2027-01-04
• Primary completion: 2029-01-04
• Completion: 2029-06-04
• First posted: 2026-04-06
• Last updated: 2026-04-13