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Exploring DNA methylation biomarkers associated with bladder cancer in patients with neurogenic bladder

A study of DNA methylation of bladder cancer markers in urine and bladder tissue of patients with neurogenic lower urinary tract dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN37551129
Enrollment
70
Registered
2023-06-14
Start date
2020-08-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Neurogenic lower urinary tract dysfunction (neurogenic bladder), screening for bladder cancer Cancer

Interventions

This study will recruit two groups of participants. 1. NLUTD Group: patients suffering from neurogenic lower urinary tract dysfunction (NLUTD) for at least 5 years, who have been scheduled for cystos

Sponsors

Aristotle University of Thessaloniki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Neurogenic lower urinary tract dysfunction group: 1. Neurogenic lower urinary tract dysfunction duration for at least 5 years scheduled for cystoscopy, wash cytology and bladder biopsy 2. Age 18 years or older 3. Consent to provide urine sample and bladder tissue Control group (healthy volunteers): 1. Age 18 years or older 2. Consent to provide urine sample

Exclusion criteria

Exclusion criteria: Neurogenic lower urinary tract dysfunction group: 1. Prior diagnosis and treatment of bladder cancer 2. History of other urinary tract malignancy Control group (healthy volunteers): 1. Lower urinary tract symptoms 2. History of urinary tract malignancy

Design outcomes

Primary

MeasureTime frame
DNA methylation of a panel of five genes’ promoters (Ras-Association domain Family member 1 [RASSF1], Retinoid Acid Receptor beta [RARß], Death-Associated Protein Kinase [DAPK], Telomerase Reverse Transcriptase [TERT] and Adenomatous Polyposis Coli [APC]) in urine measured using Quantitative Methylation Specific PCR at a single timepoint

Secondary

MeasureTime frame
DNA hypermethylation of the panel of five genes’ promoters (RASSF1, RARß, DAPK, TERT and APC) in the bladder tissue of patients suffering from neurogenic lower urinary tract dysfunction (NLUTD) measured using Quantitative Methylation Specific PCR at a single timepoint

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026