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.
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
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)
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.
Cohort
Prospective
longitudinal blood sampling and standardized neurological evaluation over 6 months
Diagnostic testProspective, multicenter, observational cohort study with longitudinal blood sampling and standardized neurological evaluation over 6 months
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).
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).
Time to onset of chronic neuropathy
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