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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Neuropathy prediction

Time frame: From enrollment to 6 months after.
- 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).

Secondary outcomes

Neuropathy severity prediction

Time frame: From enrollment to 6 months after
- 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).
Time to onset of chronic neuropathy

Time frame: from enrollment to 6 months after

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Baptiste Méric, MD

CONTACT

[email protected]

33+686961024

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Bligny

Other

Collaborators

AgenT
Hopital Forcilles

Registry information

Acronym: PRECISE1

Important dates

Study start: 2027
Primary completion: 2029
Study completion: 2029
First posted: Apr 6, 2026
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting