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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lower Urinary Track Symptoms
• Intervention / Treatment: Diagnostic test: CA19-9

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34854
    • Marmara University School of Medicine Urology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• lower urinary tract symptoms
• <18 years old

Exclusion Criteria:

• active urinary tract infections
• malignancy
• congenital urinary anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Control Group; child with haven't lower urinary tract symptoms	Diagnostic test: CA19-9; All patients Ca19-9 levels calculated from their urinary samples
Active Comparator: Norogenic Lower Urinary Tract Symptoms Group; child have lower urinary tract symptoms with neuroulogical etiology	Diagnostic test: CA19-9; All patients Ca19-9 levels calculated from their urinary samples
Active Comparator: Lower Urinary Tract Symptoms Group; They haven't norogenic etiyology	Diagnostic test: CA19-9; All patients Ca19-9 levels calculated from their urinary samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ca19-9 levels	Baseline

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: CAGRI A. SEKERCİ, MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): November 12, 2024
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ca19-9
• Other Study ID Numbers: MAR.UAD.0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No