Chemotherapy Induced Neuropathic PainPRECISE1NCT07511569
Prospective Exploratory Study of a Multiomic Blood Biomarker Panel to Predict Chemotherapy-Induced Peripheral Neuropathy (CIPN)
An observational study of Chemotherapy Induced Neuropathic Pain and Neuropathy Toxic, run by Centre Hospitalier de Bligny.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chemotherapy Induced Neuropathic Pain, Neuropathy Toxic, Taxane-induced Peripheral Neuropathy
- What is being tested?
- longitudinal blood sampling and standardized neurological evaluation over 6 months
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2027to 4 Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Chemotherapy Induced Neuropathic Pain, Neuropathy Toxic, Taxane-induced Peripheral Neuropathy, Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients
- Being tested
- longitudinal blood sampling and standardized neurological evaluation over 6 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
longitudinal blood sampling and standardized neurological evaluation over 6 monthsDiagnostic test
Prospective, multicenter, observational cohort study with longitudinal blood sampling and standardized neurological evaluation over 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathy prediction
- 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).
Measured: From enrollment to 6 months after.
Secondary outcomes (2)
Neuropathy severity prediction
- 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).
Measured: From enrollment to 6 months after
Time to onset of chronic neuropathy
Measured: from enrollment to 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start4 Jan 2027 (estimated)
- Primary completion4 Jan 2029 (estimated)
- Study completion4 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Bligny
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Forcilles, AgenT
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511569
- Sponsor's protocol ID
- 2026-001
- Acronym
- PRECISE1
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided