Trial document





This trial has been registered retrospectively.
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  DRKS00006123

Trial Description

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Title

ADOREG - development and establishment of a nationwide prospective register for Health Services Research in dermatologic oncology

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Trial Acronym

ADOREG

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the project is a medical , information technology and organizational structure and operation of an online documentation system based on the applicable data protection regulations , in which all aspects and details of the treatment of dermatological tumors in clinical practice will be coverd , stored in a central database as a prospective registry and evaluated with analysis programs for various scientific and project-related issues.
ADOREG is realized with the three sub- registers
- Malignant Melanoma
- Epithelial tumors
- Actinic keratoses

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Brief Summary in Scientific Language

ADOREG is an electronic system / register for departments of skin cancer to enter all informations of health care and therapies of patients with skin cancer (Malignant Melanoma, Epithelial Tumors and Actinic Keratosis) to serve all informations for an academic evaluation.

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Organizational Data

  •   DRKS00006123
  •   2016/05/04
  •   [---]*
  •   yes
  •   Approved
  •   13-5359-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

  •   In Pilotphase Malignant Melanoma from Stage IIB, after pilotphase Epithelial Skin Cancer and Actinic Keratosis
  •   C43-C44 -  Melanoma and other malignant neoplasms of skin
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Interventions/Observational Groups

  •   prospective data collection in a register of patients with Skin Cancer:
    - Malignant Melanoma from Stage IIB (Pilotphase)
    - Epithelial Skin Cancer
    - Actinic Keratosis
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Characteristics

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

Prospective informations about courses of treatments of patients with Malignant Melanoma from Stage IIB (Pilotphase) and also patients with epithelial Skin Cancer and Actinic Keratosis will begatherd via online portal ODM QuaSI. This is an unlimited register study.

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Secondary Outcome

Process of Health Care and Therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/09/15
  •   20000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- Malignant Melanoma from Stage IIB (Pilotphase)
- Epithelial Skin Cancer
- Actinic Keratosis

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Exclusion Criteria

No sign / confirmation of Malignant Melanoma from Stage IIB, Epithelial Skin Cancers or Actinic Ceratosis

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Essen, Hautklinik
    • Mr.  Prof. Dr.  Dirk  Schadendorf 
    • Hufelandstr. 55
    • 45122  Esseb
    • Germany
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    • Uniklinik Essen, Hautklinik
    • Mr.  Prof. Dr.  Dirk  Schadendorf 
    • Hufelandstr. 55
    • 45122  Esseb
    • Germany
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    • Uniklinik Essen, Hautklinik
    • Mr.  Prof. Dr.  Dirk  Schadendorf 
    • Hufelandstr. 55
    • 45122  Esseb
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Essen, Hautklinik
    • Mr.  Prof. Dr.  Dirk  Schadendorf 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • ONKODATAMED
    • Mr.  Dr.  Lutz  Reimer 
    • Friedenstr.58
    • 15366  Neuhagen bei Berlin
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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