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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCentre Hospitalier de Bligny

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • longitudinal blood sampling and standardized neurological evaluation over 6 months

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Centre Hospitalier de Bligny

Lead sponsor

Hopital Forcilles

Collaborator

AgenT

Collaborator