Trial document




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  DRKS00000142

Trial Description

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Title

Prospective, open, tricenter phase-III diagnostic trial to evaluate cystoscopic diagnosis of non-muscle invasive bladder cancer through narrow band imaging (NBI) in comparison to white light and photodynamic diagnosis (PDD)

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Trial Acronym

NBI/001/CD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients being suspicious to have bladder cancer usually undergo cystoscopy under white light conditions. Suspicious areas within the bladder with be biopsied or resected. The aim is to get a histological diagnosis but resection is also therapeutic.
In this trial cystoscopy will be also performed with "narrow band imaging" (NBI) as well as photodynamic diagnosis (PDD). The value in terms of tumor detection rates of all modalities will be determined.

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Brief Summary in Scientific Language

The trial aims to ivestigate cystoscopic diagnosis through "narrow band imaging" (NBI) incomparison to white light cystoscopy and photodynamic diagnosis (PDD) in non-muscle invasive bladder cancer.

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Organizational Data

  •   DRKS00000142
  •   2009/06/18
  •   [---]*
  •   yes
  •   Approved
  •   08-125, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C67 -  Malignant neoplasm of bladder
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Interventions/Observational Groups

  •   Cystoscopy under white light, NBI and PDD: order of the diagnostic methods is randomized.
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   III
  •   [---]*
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Primary Outcome

Primary endpoints are based on white light and NBI:
1. Difference of numbers of tumors per patient detected by white light and NBI
2. Difference of sensitivities of white light and NBI
3. Sensitivities of white light and NBI (all bladder cancers)
Main primary endpoint is the numbers of tumors per patient detected by white light and NBI. Auxiliary main endpoints are difference of sensitivities of white light and NBI as well as sensitivities of white light and NBI (all bladder cancers).

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Secondary Outcome

Secondary endpoint are
- Difference of detected tumors per patient
NBI and PDD
White light and PDD
- Difference of sensitivity (all bladder cancers)
NBI and PDD
White light and PDD
- Difference of specificity (all bladder cancers)
NBI and white light
NBI and PDD
White light and PDD
- Difference of recall rate (all bladder cancers)
NBI and white light
NBI and PDD
White light and PDD
- Estimation of recall rate and specificity (all bladder cancers) of
NBI
White light
PDD
- Estimation of sensitivity (all bladder cancers) of PDD
- Positive predictive values (all bladder cancers) of
NBI
White light
PDD
- Negative predicitve values (all bladder cancers) of
NBI
White light
PDD
- Estimation of recall rate, sensitivity and specificity (all bladder cancers) of NBI and PDD together
- Estimation of recall rate, sensitivity and specificity (all bladder cancers) of white light and PDD together
- Sensitivity (carcinoma in situ) of NBI, white light and PDD
- Interobserver variability of central pathology versus local pathology
- Practikability
Handling
Time requirement
Additional equipment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2009/06/23
  •   220
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

· Patients that are clinically suspicious to have bladder cancer or
· Patients that are cytologically or/and cystoscopically suspicious to have bladder cancer or
· Patients with a history of non-muscle invasive bladder cancer (except monofocal pTaG1 and >= pT2) being in follow-up
· Patient age >= 18 or <= 75 Jahre years
· Female patients not suspicious to be pregnant or/and not being pregnat
· Karnofsky Index >= 50%
· Last TUR or biopsy of the bladder or/and prostate >= 90 days
· Last intravesical metaphlaxis >= 120 days
· Written informed consent

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Exclusion Criteria

· Patients not being clinically suspicious to have bladder cancer and patients not being cytologically or/and cystoscopically suspicious to have bladder cancer and patients without a history of non-muscle invasive bladder cancer being in follow-up
· Patient age < 18 or > 75 years
- Female patients being suspicous to be pregnant or being pregnant
· Karnofsky Index < 50%
· Last TUR or biopsy of the bladder or/and prostate < 90 days
· Last intravesical metaphylaxis < 120 days
· No written informed consent

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Addresses

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    • Klinik für Urologie Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Prof. Dr. med.  Christian  Doehn 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Urologie Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Prof. Dr. med.  Christian  Doehn 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Urologie Universitätsklinikum Schleswig-Holstein Campus Lübeck
    • Mr.  Prof. Dr. med.  Christian  Doehn 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Olympus Winter & Ibe
    • Mr.  Dr. med.  Phillipe  Hall 
    • Kuehnstrasse 61
    • 22045  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/06/21
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.