ADOREG - development and establishment of a nationwide prospective register for Health Services Research in dermatologic oncology
Organizational Data
- DRKS-ID:
- DRKS00006123
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2016-05-04
- Last update in DRKS:
- 2016-05-04
- Registration type:
- Retrospective
Acronym/abbreviation of the study
ADOREG
URL of the study
No Entry
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
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.
Health condition or problem studied
- Free text:
- In Pilotphase Malignant Melanoma from Stage IIB, after pilotphase Epithelial Skin Cancer and Actinic Keratosis
- ICD10:
- C43-C44 - Melanoma and other malignant neoplasms of skin
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- prospective data collection in a register of patients with Skin Cancer: - Malignant Melanoma from Stage IIB (Pilotphase) - Epithelial Skin Cancer - Actinic Keratosis
Endpoints
- 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.
- Secondary outcome:
- Process of Health Care and Therapy
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Dermatologie Mannheim
- Medical center Dermatologie Buxtehude
- Medical center Dermatologie Mainz
- Medical center Dermatologie Dresden
- University medical center Dermatologie Essen
- University medical center Dermatologie Kiel
- Medical center Dermatologie München
- Medical center Dermatologie Münster
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-09-15
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 20000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- - Malignant Melanoma from Stage IIB (Pilotphase) - Epithelial Skin Cancer - Actinic Keratosis
Exclusion Criteria
No sign / confirmation of Malignant Melanoma from Stage IIB, Epithelial Skin Cancers or Actinic Ceratosis
Addresses
Primary Sponsor
- Address:
- Uniklinik Essen, HautklinikProf. Dr. Dirk SchadendorfHufelandstr. 5545122 EssebGermany
- Telephone:
- +492017234342
- Fax:
- +492017235935
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uk-essen.de/Hautklinik
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Uniklinik Essen, HautklinikProf. Dr. Dirk SchadendorfHufelandstr. 5545122 EssebGermany
- Telephone:
- +492017234342
- Fax:
- +492017235935
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uk-essen.de/Hautklinik
Contact for Public Queries
- Address:
- Uniklinik Essen, HautklinikProf. Dr. Dirk SchadendorfHufelandstr. 5545122 EssebGermany
- Telephone:
- +492017234342
- Fax:
- +492017235935
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uk-essen.de/Hautklinik
Principal Investigator
- Address:
- Uniklinik Essen, HautklinikProf. Dr. Dirk SchadendorfHufelandstr. 5545122 EssebGermany
- Telephone:
- +492017234342
- Fax:
- +492017235935
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uk-essen.de/Hautklinik
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- ONKODATAMEDFriedenstr.5815366 Neuhagen bei BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Private sponsorship (foundations, study societies, etc.)
- Address:
- Uniklinik Essen, HautklinikHufelandstr. 5545122 EssenGermany
- Telephone:
- +492017234342
- Fax:
- +492017235935
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uk-essen.de/Hautklinik
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-EssenRobert-Koch-Str. 9-1145147 EssenGermany
- Telephone:
- +49-201-7233637
- Fax:
- +49-201-7235837
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-02-11
- Ethics committee number:
- 13-5359-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2013-09-11
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry