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

NCT ID: NCT06785545

Last Updated: 2025-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-30

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.

Conditions

Lower Urinary Track Symptoms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Healthy Control Group

child with haven't lower urinary tract symptoms

Group Type: ACTIVE_COMPARATOR

CA19-9

Intervention Type: DIAGNOSTIC_TEST

All patients Ca19-9 levels calculated from their urinary samples

Norogenic Lower Urinary Tract Symptoms Group

child have lower urinary tract symptoms with neuroulogical etiology

Group Type: ACTIVE_COMPARATOR

CA19-9

Intervention Type: DIAGNOSTIC_TEST

All patients Ca19-9 levels calculated from their urinary samples

Lower Urinary Tract Symptoms Group

They haven't norogenic etiyology

Group Type: ACTIVE_COMPARATOR

CA19-9

Intervention Type: DIAGNOSTIC_TEST

All patients Ca19-9 levels calculated from their urinary samples

Interventions

CA19-9

All patients Ca19-9 levels calculated from their urinary samples

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• lower urinary tract symptoms
• <18 years old

Exclusion Criteria

• active urinary tract infections
• malignancy
• congenital urinary anomalies

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CAGRI A. SEKERCİ

Role: STUDY_DIRECTOR

MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY

Locations

Marmara University School of Medicine Urology Department

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MAR.UAD.0014

Identifier Type: -

Identifier Source: org_study_id