Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up (NCT06041334) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up
France50 participantsStarted 2024-01-18
Plain-language summary
The aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly.
The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated.
Volunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Spina patients consulted as part of the multidisciplinary consultation of the spina bifida rare disease reference centre;
* Written consent to participate in the research.
* Compulsory membership of a social security scheme
Exclusion Criteria:
* Patients with a non-continuous trans ileal urinary diversion ;
* Patients with enterocystoplasty;
* Untreated bacteriuria at the time of urodynamic assessment and urine sample collection;
* History of urinary tract tumour;
* History of histologically proven interstitial cystitis;
* Persons under legal protection (safeguard of justice, curatorship, guardianship);
* Persons deprived of their liberty.
* Women claiming to be pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score