Clinical trial · Observational
Prospective Exploratory Study of a Multiomic Blood Biomarker Panel to Predict Chemotherapy-Induced Peripheral Neuropathy (CIPN)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Neuropathic Pain | — | UNRESOLVED | — |
| Neuropathy Toxic | — | UNRESOLVED | — |
| Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients | — | UNRESOLVED | — |
| Taxane-induced Peripheral Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| longitudinal blood sampling and standardized neurological evaluation over 6 months | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Neuropathy prediction
- timeFrame
- From enrollment to 6 months after.
- description
- 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).
Secondary outcomes (2)
- measure
- Neuropathy severity prediction
- timeFrame
- From enrollment to 6 months after
- description
- 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).
- measure
- Time to onset of chronic neuropathy
- timeFrame
- from enrollment to 6 months after
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available