NCT06041334

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
28mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jan 2024Jul 2028

First Submitted

Initial submission to the registry

September 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 18, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2028

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

September 7, 2023

Last Update Submit

December 15, 2025

Conditions

Spina Bifida

Keywords

Spina Bifidaurinary biomarkerupper urinary tractGalloway scoreurodynamic work-upurethrocystography

Outcome Measures

Primary Outcomes (1)

  • Verify if levels of urinary biomarkers Metalloproteinase Inhibitor 2 and matrix metalloproteinase-2 are associated with Galloway score

    Logistic regression based on composite analysis of Galloway score (≤ 5 (low risk) or \>5 (high risk)) and the rate of urinary biomarkers.

    1 day

Secondary Outcomes (7)

  • Galloway score

    1 year

  • Success or failure of treatment

    1 year

  • Relationship between the success of the treatment implemented at inclusion and the level of urinary biomarkers

    1 year

  • Bladder hypocompliance based on metabolomic profile at inclusion

    0 day

  • Bladder hypocompliance based on MRI radiomic markers at inclusion

    0 day

  • +2 more secondary outcomes

Study Arms (1)

Study volunteers

OTHER
Biological: Collection of a urine sampleDiagnostic Test: Magnetic Resonance Imaging of the bladder

Interventions

Collection of a urine sampleBIOLOGICAL

Collection of a urine sample for analysis of urinary biomarkers and urinary metabolomics (Inclusion and 1 year)

Study volunteers
Magnetic Resonance Imaging of the bladderDIAGNOSTIC_TEST

Magnetic Resonance Imaging of the bladder (10 adults patients only) (Inclusion and 1 year)

Study volunteers

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, CHU de Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

LOÏC JACOB

CONTACT

0299282555loic.jacob@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 18, 2023

Study Start

January 18, 2024

Primary Completion (Estimated)

July 18, 2027

Study Completion (Estimated)

July 18, 2028

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

FR(1)