Trial document




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  DRKS00013570

Trial Description

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Title

Training and validation of an automated diagnostic deep learning algorithm in dermoscopy

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Trial Acronym

AD-LEARN DERMOSCOPY study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Non-invasive, retrospective analysis of available, beforehand generated digital images for evaluation of a computer software in comparison to conventional physicians' evaluation of dermoscopic pictures of nevi and melanoma.

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Brief Summary in Scientific Language

In this retrospective non-interventionell study the analysis of digital dermoscopic images of pigmented skin lesions (nevi and melanoma) by multiple physicians will be compared to analysis of the images by a trained deep-learning-algorithm.

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Organizational Data

  •   DRKS00013570
  •   2017/12/14
  •   [---]*
  •   yes
  •   Approved
  •   S-629/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1206-3791 
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Health Condition or Problem studied

  •   C43.9 -  Malignant neoplasm: Malignant melanoma of skin, unspecified
  •   D22.9 -  Melanocytic naevi, unspecified
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Interventions/Observational Groups

  •   In this study a retrospective analysis of available, beforehand generated digital images for evaluation of a computer software in comparison to conventional physicians' evaluation of dermoscopic pictures of nevi and melanoma will be performed.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Objective of this retrospective analysis is the assessment of the diagnostic performance of a computer algorithm in analyzing dermoscopic images in comparison to dermatologists. Diagnostic Performance will be assessed by means of sensitivity and specificity. Estimated study Duration is 12 months.

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Secondary Outcome

There are no secondary objectives in this study

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/01/16
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with dermoscopic images depicting nevi or melanoma

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Exclusion Criteria

Low Image quality

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitäts-Hautklinik Heidelberg
    • Mr.  Prof.  Holger  Haenssle 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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    • Universitäts-Hautklinik Heidelberg
    • Mr.  Prof.  Holger  Haenssle 
    • Im Neuenheimer Feld 440
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 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.