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| Name | Class |
|---|---|
| Hopital Forcilles | OTHER |
| AgenT | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Baptiste Méric, MD | Contact | 33+686961024 | jb.meric@chbligny.fr |
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4 ml of total blood will be collected for exploratory markers analysis.
Performed before the start of treatment at Visit 1 and at the 4 follow-up visits (Visits 2, 3, 4 and 5) and optional sampling if neuropathy occurs lately.
Use of K2-EDTA tubes with inversion mixing (10 times).
Centrifugation at 2,000g, without brake, at 4°C within 3 hours of collection.
Plasma stored at -80°C after aliquoting:
| Time to onset of chronic neuropathy | from enrollment to 6 months after |