Trial document



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  DRKS00013647

Trial Description

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Title

Validation of miRNA signatures for the early detection of lung cancer

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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 study is to measure markers in blood for the early detection of lung cancer. Therefore, a single blood sample is taken from a cohort of patients with suspicious X-ray or CT. This will help us to develop a blood-based test that could lead to earlier detection of lung cancer in the future and may improve survival and cure rate.

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Brief Summary in Scientific Language

The aim of the study is to evaluate a novel miRNA-based methodology for the early detection of lung cancer (NSCLC) via a blood sample in a cohort of patients with suspicious X-ray or CT. The sensitivity and specificity of the marker set for the detection of lung cancer will be ascertained.

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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

  •   DRKS00013647
  •   2018/02/05
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  •   no
  •   Approved
  •   159/2017, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  •   U1111-1208-7228 
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Health Condition or Problem studied

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

  •   Blood draw from patients with suspected lung tumor
  •   Blood draw from patients undergoing bronchoscopic evaluation of suspected non-malignant pulmonary diseases.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Validation of a previously identified signature of blood-based miRNA biomarkers for the identification of lung tumors. After measuring miRNA expression levels, it will be tested whether the signature can be used to discriminate between the two cohorts and if the results are comparable to previous tests.

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Secondary Outcome

Testing the potential of a previously identified signature of blood-based miRNA biomarkers for lung cancer screening.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/02/12
  •   303
  •   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

1. Male or female with presumable pathological findings through X-ray/CT
2. Signed informed consent
3. Patient is at least 18 years old

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Exclusion Criteria

1. History of other primary malignancies
2. Medication that influences the immune system (e.g. immunosuppressive drugs)
3. Patient is younger than 18 years

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Addresses

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    • Hummingbird Diagnostics GmbH
    • Im Neuenheimer Feld 583
    • 69120  Heidelberg
    • Germany
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    • Klinikum Konstanz Lungenzentrum / II. Medizinische Klinik
    • Mr.  Dr.  Stephan  Walterspacher 
    • Luisenstr. 7
    • 78464  Konstanz
    • Germany
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    • Klinikum Konstanz Lungenzentrum / II. Medizinische Klinik
    • Mr.  Dr.  Stephan  Walterspacher 
    • Luisenstr. 7
    • 78464  Konstanz
    • Germany
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Sources of Monetary or Material Support

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    • Hummingbird Diagnostics GmbH
    • Im Neuenheimer Feld 583
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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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.