Trial document




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  DRKS00016939

Trial Description

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Title

Prospective cross-sectional study on occupational UV exposure, risk awareness and preventive measures in patients with malignant melanoma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients with malignant melanoma are examined once for their occupational exposure to UV radiation, which types of melanoma occurred, and whether certain types of melanoma were increasingly found in light-damaged areas of the body. Hypothetically, an increased incidence of lentigo-maligna melanoma in UV-exposed areas can be expected. Furthermore, the awareness of the harmfulness of UV radiation is queried , and whether preventive measures were taken against UV radiation in the workplace. These data are collected by examining and completing questionnaires.

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Brief Summary in Scientific Language

Patients with malignant melanoma are interviewed once with questionnaires about their occupational history as well as their UV exposure. Data about the Melanoma subtype and localisation are collected, as well as clinical patient data (e.g. Skin type according to Fitzpatrick). Hypothetically, an increased incidence of lentigo-maligna melanoma in UV-exposed areas can be expected. The awareness of the harmfulness of UV radiation is queried, and whether preventive actions were taken against UV radiation in the workplace. These data are collected by questionnaires (e.g. SIMBO-C).

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Organizational Data

  •   DRKS00016939
  •   2019/10/25
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  •   yes
  •   Approved
  •   2019-258-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

  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   Patients with malignant melanoma are interviewed once with questionnaires about their occupational history as well as their UV exposure. Disease data related to the melanoma are recorded once.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoint: type of melanoma diagnosed once by histology. Localization of the melanoma diagnosed by single examination. Occupational UV exposure, once queried by questionnaire.

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Secondary Outcome

Measurement by questionnaire: awareness of the risk of UV radiation, application of protective measures.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/11/03
  •   405
  •   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

- Diagnosis of a malignant melanoma of each stage
- Presence of written consent to study participation

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Exclusion Criteria

Existence of a serious mental illness or disability

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Addresses

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    • Fachklinik Hornheide
    • Mr.  Priv.-Doz. Dr.  Hans-Joachim  Schulze 
    • Dorbaumstrasse 300
    • 48157  Münster
    • Germany
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    • Fachklinik Hornheide
    • Ms.  Dr.  Susanne  Dugas-Breit 
    • Dorbaumstrasse 300
    • 48157  Münster
    • Germany
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    • Fachklinik Hornheide
    • Ms.  Dr.  Susanne  Dugas-Breit 
    • Dorbaumstrasse 300
    • 48157  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung
    • Mr.  Meik  Schnabel 
    • Gartenstrasse 194
    • 48147  Münster
    • Germany
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Status

  •   Recruiting planned
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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.