Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05362539
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2022-04-27
Brief Title:
Novel Urine-Based DNA Methylation Biomarkers for Urothelial Bladder Carcinoma Detection in Patients With Hematuria
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Novel Urine-Based DNA Methylation Biomarkers for Urothelial Bladder Carcinoma Detection in Patients With Hematuria
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study aimed to assess the diagnostic performance of novel urine-based DNA hypermethylation of six genes GATA4 P16 P14 APC CDH1 and CD99 for UBC detection in patients with hematuria
Detailed Description:
According to GLOBOCAN data bladder cancer BC is considered a major health problem that represents 3 of all cancer diagnoses Urothelial bladder carcinoma UBC accounts for the vast majority 90 of BC cases with predominance of non-muscle invasive disease Ta Tis or T1 in 75 of patients while others show muscle invasion T2-4
In refereed population UBC is usually diagnosed as a result of work-up for hematuria at a rate of 2-5 following an evaluation of asymptomatic microscopic hematuria and up to 5-15 of patients with macroscopic hematuria Therefore a timely prompt evaluation of hematuria can give to earlier diagnosis and better survival of UBC
Currently cystoscopy cross sectional imaging are the gold standard tools for UBC diagnosis in patients with hematuria Unfortunately these costly invasive and painful diagnostics could miss early smallflat bladder lesions Urine cytology has been proposed as a non-invasive alternative test with high specificity however it lacks sensitivity for diagnosis of low grade LG tumors
Over the last decades multiple researches have output different markers for UBC diagnosis Based on their target of assessment these markers include screening for soluble antigens BTA-Stat NMP-22 surviving etc cell surface antigens Cytokeratins and UroVysion genomic markers Cxbladder and Xpert and urinary metabolomics CRAT and SLC25A20 However most of these markers are limited by unsatisfying diagnostic performance high cost or lack of validation
Several preliminary studies have shown that DNA methylation a critical step in transcription regulation is chemically stable and can be precisely quantified making it an attractive marker for UBC detection Both local and global DNA hypermethylation in BC specimens are usually associated with inactivation of tumor suppressor genes These methylations changes could be effectively identified in urine sediments as well as tumor tissues
In the current literature multiple studies investigated the performance of DNA hypermethylation of either individual or panel genes with reported sensitivity SN and specificity SP values that range from 40-95 and 10-100 respectively Most of these studies were limited by tumor characteristics heterogeneity majority were T2 and high grade HG disease which did not reflect the daily practice inclusion of different BC histological variants lack of external validation and small sample size
The aim of our study is to assess the diagnostic performance of novel urine-based DNA methylation six genes GATA4 P16 P14 APC CDH1 and CD99 for UBC detection in patients with hematuria Moreover we investigated the methylation pattern of these genes in different stages and grades of UBC
In refereed population UBC is usually diagnosed as a result of work-up for hematuria at a rate of 2-5 following an evaluation of asymptomatic microscopic hematuria and up to 5-15 of patients with macroscopic hematuria Therefore a timely prompt evaluation of hematuria can give to earlier diagnosis and better survival of UBC
Currently cystoscopy cross sectional imaging are the gold standard tools for UBC diagnosis in patients with hematuria Unfortunately these costly invasive and painful diagnostics could miss early smallflat bladder lesions Urine cytology has been proposed as a non-invasive alternative test with high specificity however it lacks sensitivity for diagnosis of low grade LG tumors
Over the last decades multiple researches have output different markers for UBC diagnosis Based on their target of assessment these markers include screening for soluble antigens BTA-Stat NMP-22 surviving etc cell surface antigens Cytokeratins and UroVysion genomic markers Cxbladder and Xpert and urinary metabolomics CRAT and SLC25A20 However most of these markers are limited by unsatisfying diagnostic performance high cost or lack of validation
Several preliminary studies have shown that DNA methylation a critical step in transcription regulation is chemically stable and can be precisely quantified making it an attractive marker for UBC detection Both local and global DNA hypermethylation in BC specimens are usually associated with inactivation of tumor suppressor genes These methylations changes could be effectively identified in urine sediments as well as tumor tissues
In the current literature multiple studies investigated the performance of DNA hypermethylation of either individual or panel genes with reported sensitivity SN and specificity SP values that range from 40-95 and 10-100 respectively Most of these studies were limited by tumor characteristics heterogeneity majority were T2 and high grade HG disease which did not reflect the daily practice inclusion of different BC histological variants lack of external validation and small sample size
The aim of our study is to assess the diagnostic performance of novel urine-based DNA methylation six genes GATA4 P16 P14 APC CDH1 and CD99 for UBC detection in patients with hematuria Moreover we investigated the methylation pattern of these genes in different stages and grades of UBC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None