Prospective Exploratory Study of a Multiomic Blood Biomarker Panel to Predict Chemotherapy-Induced Peripheral Neuropathy (CIPN) (PRECISE1)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Taxane-induced Peripheral Neuropathy; Chemotherapy Induced Neuropathic Pain; Neuropathy Toxic; Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
• Intervention / Treatment: Diagnostic test: longitudinal blood sampling and standardized neurological evaluation over 6 months

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.

• Study Type: Observational
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Baptiste Méric, MD; Phone Number: 33+686961024; Email: jb.meric@chbligny.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathy severity prediction	2. To predict the occurrence of severe CIPN that significantly impacts the therapeutic course, defined as chronic neuropathy resulting in the permanent discontinuation or a significative dose-reduction (≥15% of planned dose at any time in the treatment course) of neurotoxic agent, in each of the two treatment subgroups (taxanes and oxaliplatin).	From enrollment to 6 months after
Time to onset of chronic neuropathy		from enrollment to 6 months after

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Bligny
• Collaborators: Hopital Forcilles; AgenT

Study record dates

Study Major Dates

• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): January 4, 2029
• Study Completion (Estimated): June 4, 2029

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No