Trial document





This trial has been registered retrospectively.
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  DRKS00000199

Trial Description

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Title

Development and evaluation of diagnostic biomarker panels on the basis of microarray analysis for treatment planning of oral squamous cell carcinoma

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Trial Acronym

Biomarker Panel

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of our project was to develop a simple and economic device to diagnose and categorize the oral squamous cell carcinoma on the basis of clinical data combined with genetic alterations.
The innovative approach is to use the information of aberrant genetic patterns of malignantly altered tissue in an easy, reliable reproducible laboratory technique.

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Brief Summary in Scientific Language


The aim of our study is to develop a biomarker panel on the basis of gene expression anlysis by microarray technique. With the information of the altered gene expression of few selected marker genes a precise diagnosis, prognosis and individually adapted therapy regimen will be established.
The requirement for this biomolecular diagnostic tool is to be reliable, cost-efficient, quick and sensitive.

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Organizational Data

  •   DRKS00000199
  •   2011/01/13
  •   [---]*
  •   no
  •   Approved
  •   2008-580-f-s, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   oral squamous cell carcinoma
  •   C06.9 -  Malignant neoplasm: Mouth, unspecified
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
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Primary Outcome

The aim of our study is to develop a biomarker panel on the basis of gene expression anlysis by microarray technique. With the information of the altered gene expression of few selected marker genes a precise diagnosis, prognosis and individually adapted therapy regimen will be established.
The requirement for this biomolecular diagnostic tool is to be reliable, cost-efficient, quick and sensitive.
The microarray analysis of the collected samples is carried out at the moment with special softwear and not finished yet.

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Secondary Outcome

One aim of our project was to develop a simple and economic device to diagnose and categorize the oral squamous cell carcinoma on the basis of clinical data combined with genetic alterations.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2009/04/15
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

histologically diagnosed squamous cell carcinoma of the oral cavity,
no adjuvant therapy

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Exclusion Criteria

inoperability,
tumour entities other than squamous cell carcinoma

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Addresses

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    • Pro Inno II AiF Projekt GmbH
    • Tschaikowskistraße 49
    • 13156  Berlin
    • Germany
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    • Mund- und Kiefer-Gesichtschirurgie Universitätsklinikum Münster
    • Mr.  Prof. Dr. med. Dr. med. dent.  Johannes  Kleinheinz 
    • Waldeyerstrasse 30
    • 48149   Münster
    • Germany
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    • Mund- und Kiefer-Gesichtschirurgie Universitätsklinikum Münster
    • Mr.  Prof. Dr. med. Dr. med. dent.  Johannes  Kleinheinz 
    • Waldeyerstrasse 30
    • 48149   Münster
    • Germany
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Sources of Monetary or Material Support

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    • AiF e.V. Arbeitsgemeinschaft industrieller Forschungsvereinigungen "Otto von Guericke" e.V.
    • Bayenthalgürtel 23
    • 50968  Köln
    • Germany
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    • Bundesministerium für Wirtschaft und Technologie BMWi Berlin
    • Scharnhorststr. 34-37
    • 10115   Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.