NCT06817707 Evaluation of Urinary Dysfunction in CANVAS Patients
| NCT ID | NCT06817707 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Cerebellar Ataxia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-03-21 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigator wishes to evaluate the prevalence of urinary symptoms in patients diagnosed with Cerebellar Ataxia, Neuropathy, Vestibular Areflexia Syndrome (CANVAS). As much as one third of patients living with CANVAS experience symptoms of urinary system dysfunction. The primary objective of this study is to evaluate the incidence of urinary symptoms in these patients, as well as the potential complications that might occur at the level of the upper and lower urinary system. The investigator also wishes to analyse the connection between the severity of the neurological deficits, the presence of dysautonomia and the presence of urinary dysfunction. To that end, the data collected in the study will concern : a detailed neurological examination including SARA (Scale for the assessement and rating of ataxia) scale assessement, laboratory tests of the renal function, dysautonomia tests with Sudoscan and research of orthostatic hypotension, urinary function questionnaires, dysautonomia questionnaire, urodynamic tests and urinary system ultrasound.
Eligibility Criteria
Inclusion Criteria: * 18 years old and more * genetic confirmation of CANVAS (presence of pathogenic penta nucleotide expansion in both alleles of the replication factor C subunit 1(RFC1) gene or pathological penta nucleotide expansion in the heterozygous state associated with a truncating mutation on the second allele of the RFC1 gene) * Able to undergo renovesical ultrasound and urinary flow measurement; * Having given informed consent in writing; * Negative pregnancy test for people on childbearing age; * Social security affiliated Exclusion Criteria: * Presenting another urological pathology of base, not related to CANVAS; * Having undergone a urological intervention within the 6 months preceding the screening visit; * Presenting a condition that is incompatible with the proper conduct of the study as determined by the physician; * Protected by law under guardianship or curators, or not able to participate in a clinical study pursuant to article L. 1121-16 of the French Public Health Code * Pregnant or breastfeeding women for women of childbearing age
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06817707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebellar Ataxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06817707 currently recruiting?
Yes, NCT06817707 is actively recruiting participants. Contact the research team at ezaru.a@chu-nice.fr for enrollment information.
Where is the NCT06817707 trial being conducted?
This trial is being conducted at Nice, France, Montpellier, France, Lille, France.
Who is sponsoring the NCT06817707 clinical trial?
NCT06817707 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 40 participants.