Trial document

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DRKS-ID: DRKS00003592

Trial Description

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Title

Urinary LASP-1 as diagnostic marker for detection of transitional cell carcinoma of the urinary bladder

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The detection of the protein LASP-1 in the urine is associated with a 85% sensitivity and specificty for the presence of bladder cancer. After promising initial results (Ardelt et al, Urol Oncol, 2012, in press) this study will further evaluate the diagnostic use. Eligible are patients with the suspicion of bladder cancer who undergo a cystoscopic evaluation.

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Brief Summary in Scientific Language

Urinary LASP-1 has recently been shown to be predictive for presence of a transitional cell carcinoma of the bladder due to enhanced cell shedding through and an increased expression of LASP-1. This study will further analyse the diagnostic value and perform a multivariate analysis of confounding factors. Eligible are all patients with suspicion of bladder cancer.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00003592
Date of Registration in DRKS: 2012/03/08
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 79/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

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Secondary IDs

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Health Condition or Problem studied

ICD10: C67 - Malignant neoplasm of bladder

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Interventions/Observational Groups

Arm 1: Patiens with Bladder tumor. The urinary LASP-1 content ist measured.
Arm 2: Healthy donors, patients without tumor(verified by cystoscopy and/or biopsy. The urinary LASP-1 content is measured.

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Other
Allocation: Non-randomized controlled trial
Blinding: Blinded
Who is blinded: assessor
Control: Other
Purpose: Diagnostic
Assignment: Other
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

Measurement of urinary LASP-1 content. Korrelation to cystoscopical and/or histological result. Multivariate analysis of sensitivity, specificity, positive and negative predictive value. Confounding factors, such as tumor size, grading, staging will be included

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Secondary Outcome

none

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Countries of Recruitment

DE: Germany
CH: Switzerland

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Locations of Recruitment

University Medical Center Chirugische Universitätsklinik, Abteilung f. Urologie, Freiburg im Breisgau

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2012/05/01
Target Sample Size: 1000
Monocenter/Multicenter trial: Multicenter trial
National/International: International

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 1 Years
Maximum Age: 99 Years

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Additional Inclusion Criteria

Any patient with suspected bladder cancer

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Exclusion Criteria

None

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Addresses

Primary Sponsor
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- Chirurgische Universtitätsklinik, Abteilung Urologie Universitätsklinik Freiburg
- Mr. Dr Peter Ardelt
- Hugstetter Strasse 55
- 79106 Freiburg
- Germany
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- Telephone: 0761 27028930
- Fax: 0761 27028960
- E-mail: peter.ardelt at usb.ch
- URL: [---]*
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Contact for Scientific Queries
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- Chirurgische Universitätsklinik, Abteilung für Urologie
- Mr. Dr Peter Ardelt
- Hugstetter Strasse 55
- 79106 Freiubrg
- Germany
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- Telephone: 0761 270 28930
- Fax: 0761 270 28936
- E-mail: peter.ardelt at usb.ch
- URL: http://www.uniklinik-freiburg.de
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Contact for Public Queries
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- Chirurgische Universitätsklinik, Abteilung für Urologie
- Mr. Dr Fabian Adams
- Hugstetter Strasse 55
- 79106 Freiburg
- Germany
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- Telephone: 0761 270 28930
- Fax: 0761 270 28936
- E-mail: fabian.adams at uniklinik-freiburg.de
- URL: http://www.uniklinik-freiburg.de
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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- Chirurgische Universitätsklinik, Abteilung für Urologie
- Mr. Dr Peter Ardelt
- Hugstetter Strasse 55
- 79106 Freiubrg
- Germany
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- Telephone: 0761 270 28930
- Fax: 0761 270 28936
- E-mail: peter.ardelt at uniklinik-freiburg.de
- URL: http://www.uniklinik-freiburg.de
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Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Stiftung für Pathobiochemie und Molekulare Diagnostik
- Maximiliansstrasse 6
- 76133 Karlsruhe
- Germany
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- E-mail: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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