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Trial registered on ANZCTR


Registration number
ACTRN12620000258954
Ethics application status
Approved
Date submitted
19/01/2020
Date registered
27/02/2020
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Date results information initially provided
27/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
DNA Hypermethylation of a panel of 5 genes in urine samples as biomarker for bladder cancer diagnosis
Scientific title
DNA Hypermethylation of a panel of 5 genes as an urinary biomarker for bladder cancer diagnosis.
Secondary ID [1] 300255 0
None
Universal Trial Number (UTN)
U1111-1246-4201
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder cancer 315814 0
Condition category
Condition code
Cancer 314105 314105 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The participants, patients and health individuals, provided a single urine sample (single cross-sectional assessment) before any routine diagnostic or therapeutic intervention. Only the patients underwent cystoscopy and transurethral resection of the bladder tumour.
Intervention code [1] 316524 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy individuals without previous history of any malignancy
Control group
Active

Outcomes
Primary outcome [1] 322494 0
Sensitivity and specificity of the methylation status of a panel of 5 gene promoters in diagnosis of bladder cancer as assessed by urine samples using univariate statistical analysis of the methylated status of the patients and healthy individuals, this is a composite outcome'
Timepoint [1] 322494 0
Day 1
Secondary outcome [1] 378712 0
The diagnostic accuracy of the methylation status of each gene promoter in diagnosis of bladder cancer as assessed by urine samples using univariate statistical analysis and logistic regression of the methylated status of the patients and healthy individuals.
Timepoint [1] 378712 0
day 1

Eligibility
Key inclusion criteria
Patients group: Subjects with Bladder Cancer who are able to provide a urine sample and undergo a cystoscopy before any treatment.

Control group: Subjects without any previous or current malignancy who are able to provide a urine sample.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with metastasis to urinary bladder from other organs or other malignancies

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Descriptive statistics, univariate analysis, Shapiro Wilk normality test, Mann-Whitney for comparison of two independent non parametric samples as well as exact and logistic regression were used for all variables with meaningful number of data points between patients and controls. ROC analysis was performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22219 0
Greece
State/province [1] 22219 0

Funding & Sponsors
Funding source category [1] 304678 0
Commercial sector/Industry
Name [1] 304678 0
Astellas Pharmaceuticals A.E.B.E.
Address [1] 304678 0
6-8 Agisilaou Str., 151 23 Marousi, Athens, Greece
Country [1] 304678 0
Greece
Funding source category [2] 304680 0
University
Name [2] 304680 0
Research Committee of Aristotle University of Thessaloniki
Address [2] 304680 0
3rd September Str. - University Campus
546 36 Thessaloniki, Greece
Country [2] 304680 0
Greece
Primary sponsor type
University
Name
Research Committee of Aristotle University of Thessaloniki
Address
3rd September Str. - University Campus
546 36 Thessaloniki, Greece
Country
Greece
Secondary sponsor category [1] 304997 0
None
Name [1] 304997 0
Address [1] 304997 0
Country [1] 304997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305100 0
Committee for Bioethics and Ethics of Medical School of Aristotle University of Thessaloniki
Ethics committee address [1] 305100 0
New Auditorium Building, 1st floor
(Across the main entrance of AHEPA Hospital)
Aristotle University of Thessaloniki
University Campus
54124 Thessaloniki
Ethics committee country [1] 305100 0
Greece
Date submitted for ethics approval [1] 305100 0
Approval date [1] 305100 0
04/06/2014
Ethics approval number [1] 305100 0

Summary
Brief summary
The aim of this study is to measure the diagnostic accuracy (sensitivity and specificity) of a panel of five methylated gene promoters in urine samples for the detection of bladder cancer , whose sensitivity and specificity has been proven when studied in a separate fashion. Ideally, this would lead to the development of a DNA methylation-based diagnostic protocol in urine samples and optimisation of its sensitivity and specificity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99270 0
Prof Apostolos Apostolidis
Address 99270 0
"Papageorgiou" General Hospital, 2nd Dept. of Urology, Ring Road, Nea Efkarpia, 56403, Thessaloniki, Greece
Country 99270 0
Greece
Phone 99270 0
+306944529898
Fax 99270 0
Email 99270 0
zefxis@yahoo.co.uk
Contact person for public queries
Name 99271 0
Mr Petros Georgopoulos
Address 99271 0
"Papageorgiou" General Hospital, 2nd Dept. of Urology, Ring Road, Nea Efkarpia, 56403, Thessaloniki, Greece
Country 99271 0
Greece
Phone 99271 0
+30 457 133 0800
Fax 99271 0
Email 99271 0
petrosg54@yahoo.gr
Contact person for scientific queries
Name 99272 0
Prof Apostolos Apostolidis
Address 99272 0
"Papageorgiou" General Hospital, 2nd Dept. of Urology, Ring Road, Nea Efkarpia, 56403, Thessaloniki, Greece
Country 99272 0
Greece
Phone 99272 0
+30 231 332 3737
Fax 99272 0
Email 99272 0
zefxis@yahoo.co.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6466 0
Ethical approval
Citation [1] 6466 0
Link [1] 6466 0
Email [1] 6466 0
Other [1] 6466 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary