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

NCT06785545 | Unknown

• 1 other identifier: MAR.UAD.0014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Track Symptoms

Keywords

ca19-9

Outcome Measures

Primary Outcomes (1)

• Ca19-9 levels

  Baseline

Study Arms (3)

Healthy Control Group

ACTIVE COMPARATOR

child with haven't lower urinary tract symptoms

Diagnostic Test: CA19-9

Norogenic Lower Urinary Tract Symptoms Group

ACTIVE COMPARATOR

child have lower urinary tract symptoms with neuroulogical etiology

Diagnostic Test: CA19-9

Lower Urinary Tract Symptoms Group

ACTIVE COMPARATOR

They haven't norogenic etiyology

Diagnostic Test: CA19-9

Interventions

CA19-9 DIAGNOSTIC_TEST

All patients Ca19-9 levels calculated from their urinary samples

Healthy Control Group; Lower Urinary Tract Symptoms Group; Norogenic Lower Urinary Tract Symptoms Group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• lower urinary tract symptoms
• \<18 years old

You may not qualify if:

• active urinary tract infections
• malignancy
• congenital urinary anomalies

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Istanbul, 34854, Turkey (Türkiye)

Location

Study Officials

• CAGRI A. SEKERCİ

  MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 21, 2025
• Study Start: January 1, 2024
• Primary Completion: November 12, 2024
• Study Completion: January 30, 2025
• Last Updated: January 21, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)