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Urinary CA19-9 Level in the Differential Diagnosis of Neurogenic and Non-Neurogenic Lower Urinary Tract Dysfunction in Children

The Value of Urinary CA19-9 Level in the Differential Diagnosis of Neurogenic and Non-Neurogenic Lower Urinary Tract Dysfunction in Children

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06785545
Enrollment
100
Registered
2025-01-21
Start date
2024-01-01
Completion date
2025-01-30
Last updated
2025-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Urinary Track Symptoms

Keywords

ca19-9

Brief summary

It has been shown in the literature that urinary CA19-9 levels are associated with the degree of hydronephrosis and the anteroposterior diameter of the renal pelvis. Additionally, this marker has been reported as a potential indicator of kidney damage related to obstructive uropathies. A study conducted in our clinic, which has yet to be published, investigated CA19-9 levels in children with hydronephrosis of different etiologies. It found a statistically significant difference in CA19-9 levels between children with neurogenic and non-neurogenic lower urinary tract (LUT) dysfunction (Evaluation of Spot Urine Carbohydrate Antigen 19-9, Sodium, Potassium, and Creatinine Levels as Biomarkers for Differential Diagnosis of Hydronephrosis and Detection of Kidney Damage in Children Aged 0-16: A Prospective Study, Kütükoğlu et al.). Based on this, the hypothesis was formulated that urinary CA19-9 might be a potential biomarker for indicating neurological deficits in children presenting with LUT symptoms. Therefore, this study aimed to compare CA19-9 levels in a larger group of children with neurogenic and non-neurogenic LUT dysfunction.

Detailed description

A total of 25 children with non-neurogenic etiologies and 25 children with neurogenic etiologies who presented to our clinic with LUT dysfunction were prospectively included in the study. A control group of 15 healthy children was also included. Urine samples were collected from the children, centrifuged at 3000 rpm for 4 minutes, and stored at -25°C. Urinary CA19-9 was analyzed using ELISA, and creatinine levels were measured for configuration in the spot urine samples. Additionally, for the neurogenic group, scintigraphy, urinary ultrasonography, voiding cystourethrography, and urodynamic (UD) parameters were recorded. Children with active urinary tract infections, malignancy, or congenital urinary anomalies were excluded from the study. Urinary CA19-9 levels were compared between the groups, and subgroup analysis was performed within the neurogenic group based on urodynamic parameters and the presence of upper urinary tract (UUT) damage. The presence of vesicoureteral reflux, hydronephrosis, or renal scarring was considered as UUT damage.

Interventions

DIAGNOSTIC_TESTCA19-9

All patients Ca19-9 levels calculated from their urinary samples

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* lower urinary tract symptoms * \<18 years old

Exclusion criteria

* active urinary tract infections * malignancy * congenital urinary anomalies

Design outcomes

Primary

MeasureTime frame
Ca19-9 levelsBaseline

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026