Trial document





This trial has been registered retrospectively.
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  DRKS00017152

Trial Description

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Title

Systematic Evaluation of the Predictive Importance of Tumor Cell Content Indicators of Endoscopic Samples for Molecular Examinations in Patients with NSCLC

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The aim of the project is to identify tumor cell content indicators of endoscopic NSCLC samples as part of the sampling process in order to ensure a successful molecular analysis of the necessary biomarkers.

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Brief Summary in Scientific Language

The increasing relevance and number of molecular assays in patient care and research in patients with advanced non-small cell lung carcinoma (NSCLC) is placing increasing demands on the sample material and its processing. Since the molecular examinations are usually performed on small, endoscopically obtained samples, on the one hand the maximization of the possible determinable, relevant targets and with it the optimization of the molecular procedures and on the other hand the protection of patients with advanced tumor disease are important. The goal must therefore be the optimal use of existing material in the analysis or the extraction of sufficient material, especially in critical cases.
Since in the near future, further biomarkers, such as e.g. the burden of tumor mutation as a criteria for immuno-oncological therapeutic approaches is to be introduced into everyday clinical practice, it is foreseeable that the requirements for the starting material of the assays will increase even further.
The aim of the project is therefore to retrospectively identify tumor cell content indicators of endoscopic NSCLC samples as part of the sampling procedure in order to ensure a successful molecular analysis of the necessary biomarkers. The identification of a surrogate parameter for successful molecular analysis would also provide the basis for the comparability of different biopsy methods in the future.
For this purpose, samples obtained in the context of regular diagnostics in the department of interventional bronchology are to be examined for potential markers of a later successful molecular pathological analysis. The samples were processed in the usual way standardized and processed further diagnostically in the Institute of Pathology.

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Organizational Data

  •   DRKS00017152
  •   2019/07/22
  •   [---]*
  •   yes
  •   Approved
  •   18-8502-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Single Arm Study, endobronchial ultrasound in the context of tumor diagnostics, sample processing in pathology, retrospective sample evaluation as result of the study
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The aim of the project is to identify tumor cell content indicators of endoscopic NSCLC samples as part of the sampling process in order to ensure a successful molecular analysis of the necessary biomarkers.

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Secondary Outcome

Sample weight, complications and macroscopic assessment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/12/12
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

NSCLC Stage IV

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Exclusion Criteria

Contraindication Rigid Bronchoscopy / EBUS

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Addresses

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    • Ruhrlandklinik
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    •   00492014330
    •   [---]*
    •   [---]*
    •   [---]*
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    • Ruhrlandklinik
    • Mr.  PD Dr.  Kaid  Darwiche 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik
    • Ms.  Birte  Schwarz 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Ruhrlandklinik
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    •   00492014330
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2019/05/30
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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.