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NCT04262778: SUDOPED

Diagnostic of Chemotherapy Induced Neuropathy in Children

Completed Last updated 20 November 2025
What this trial tests

trial testing electrochemical skin conductance measurement in Chemotherapy-induced Peripheral Neuropathy in 55 participants. Completed in 8 September 2023.

Timeline
20 October 2020
Primary endpoint
20 April 2023
8 September 2023

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
StatusCompleted
Study typeOBSERVATIONAL
Enrollment55
Start date20 October 2020
Primary completion20 April 2023
Estimated completion8 September 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 5 to 17, any sex, with Chemotherapy-induced Peripheral Neuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the diagnostic accuracy of a newly developed tool (Electrochemical Skin Conductances (ESC) measurement) easy-to-perform, non-invasive, highly reproductible and not requiring specific training, to identify pediatric chemotherapy-induced-peripheral-neuropathies (CIPN). CIPN are a frequent (20 to 75% depending on the drug), early and potentially severe long-lasting and dose limiting adverse effect of treatments in immuno-hematology and cancerology. The pathophysiology, the chronology of injury (ie small then large sensory nerve fiber or vice-versa) and the age-related short/long-term impact on peripheral nerves remain largely not understood. Clinical signs of CIPN are highly heterogenous, often under-recognized and include diverse sensory symptoms and pain. Persistent loss of sensation and strength as well as neuropathic pain may have a short/long-term impact in term of functional limitations and quality of life. There is a lack of specific and sensitive measurement tools for CIPN in the pediatric population. Neurophysiological tools (except electro-neuro-myography allowing only the assessment of large myelinated nerves) are not implemented in the pediatric oncology-hematology everyday practice: they are often invasive and/or poorly reproducible, not accessible for "bedside" follow-up, and lacking normative values, thus often dedicated only to research. ESC may provide an early and quantitative assessment of small fiber dysfunction in children, a prerequisite for the identification of additional preventive or curative approaches in CIPN.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Chemotherapy-induced Peripheral Neuropathy

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing