Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000947808
Ethics application status
Not yet submitted
Date submitted
28/08/2012
Date registered
5/09/2012
Date last updated
5/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of fluorescence in situ hybridization (FISH) in the early detection of bladder cancer using Photodynamic diagnosis (PDD)
Scientific title
The role of fluorescence in situ hybridization (FISH) in the early detection of bladder cancer using PDD
Secondary ID [1] 281107 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bladder cancer 287266 0
Condition category
Condition code
Cancer 287591 287591 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A multicolour-fluorescence in situ hybridization (FISH) approach will be performed on a liquid-based washing urinary cytology and on suspicious lesions in all participants. This will be performed once in all cases. The duration of fluorescence in situ hybridization and the histopathologic evaluation will be performed by our uro-pathologist. They will each last approximately two days. It will neither mean longer hospitalization nor more than the usual tissue specimens for all patients.
Intervention code [1] 285559 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287852 0
To investigate, whether through PDD identified and histologically diagnosed false-positive-lesions, are not indeed already anticipatory lesions with chromosomal aberrations.
Timepoint [1] 287852 0
The first results and primary outcomes will be assessed after twelve months.
Secondary outcome [1] 298936 0
Nil
Timepoint [1] 298936 0
Nil

Eligibility
Key inclusion criteria
urothelial carcinoma of the bladder
Minimum age
21 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4512 0
Italy
State/province [1] 4512 0
Bolzano (BZ)

Funding & Sponsors
Funding source category [1] 285889 0
Hospital
Name [1] 285889 0
Central Hospital of Bolzano
Country [1] 285889 0
Italy
Primary sponsor type
Hospital
Name
Central Hospital of Bolzano
Address
Lorenz-Boehler-Street 5
39100 Bolzano
Country
Italy
Secondary sponsor category [1] 284713 0
None
Name [1] 284713 0
Address [1] 284713 0
Country [1] 284713 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287918 0
Ethics committee address [1] 287918 0
Ethics committee country [1] 287918 0
Date submitted for ethics approval [1] 287918 0
01/01/2013
Approval date [1] 287918 0
Ethics approval number [1] 287918 0

Summary
Brief summary
The percentage of the false positive lesions in photodynamic diagnosis (PDD) ranges between 7,1% and 47% in the literature.
Careful interpretation and indication of PDD is necessary in case of previous instillation therapy especially with BCG and false positive rates of 64%.
Whether histologically proven false positive fluorescence is caused by early malignant genetic changes has been discussed but is still the object of research..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34629 0
Address 34629 0
Country 34629 0
Phone 34629 0
Fax 34629 0
Email 34629 0
Contact person for public queries
Name 17876 0
Thomas Martini
Address 17876 0
Heinrich-Fuchs-Str. 103
69126 Heidelberg
Germany
Country 17876 0
Germany
Phone 17876 0
+49(0)17631243718
Fax 17876 0
Email 17876 0
[email protected]
Contact person for scientific queries
Name 8804 0
Thomas Martini
Address 8804 0
Heinrich-Fuchs-Str. 103
69126 Heidelberg
Germany
Country 8804 0
Germany
Phone 8804 0
+49(0)17631243718
Fax 8804 0
Email 8804 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.