Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013298

Trial Description

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Title

Oncologic Outcome and Quality of Life of patients with node negative vulvar cancer after sentinel node biopsy or systematic inguino-femoral lymphadenectomy - an epidemiological investigation

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Trial Acronym

VulvaN0

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URL of the Trial

http://keine

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Brief Summary in Lay Language

Study of oncology outcome and Quality of life of patients with vulvar cancer without lymph node metastasis.

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Brief Summary in Scientific Language

Study of oncology outcome and Quality of life of patients with vulvar cancer without lymph node metastasis.

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Organizational Data

  •   DRKS00013298
  •   2019/01/25
  •   [---]*
  •   yes
  •   Approved
  •   18-381, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C51 -  Malignant neoplasm of vulva
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Interventions/Observational Groups

  •   Vulvar cancer Stage T1/2 with sentinel node biopsy
    Survey of Outcome and QoL (Quality of Life)
  •   Vulvar cancer Stage T1/2 with inguino-femoral lymph node metastasis
    Survey of Outcome and QoL (Quality of Life)
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Disease free survival; Local recurrence or distant metastasis found by MRI, CT or ultrasound scan found in regular Tumor follow up.

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Secondary Outcome

Quality of Life by SF 12(R) questionaire one-time of follow up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/12/21
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   20   Years
  •   99   Years
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Additional Inclusion Criteria

Node negative Vulvar cancer

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Exclusion Criteria

Lymphnode metastasis
Advanced vulvar cancer FIGO Stage III/IV

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Evangelisches Krankenhaus Kalk
    • Mr.  PD Dr.  Dirk M.  Forner 
    • Buchforststr. 2
    • 51103  Köln
    • Germany
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    • Kaiserswerther DiakonieFlorence Nightingale Krankenhaus
    • Mr.  Prof. Dr.  Björn  Lampe 
    • Kreuzbergstr. 79
    • 40489  Düsseldorf
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinikum KölnKlinik und Poliklinik für Gynäkologie und Geburtshilfe
    • Mr.  Porf. Dr.   Peter   Mallmann 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Evangelisches Krankenhaus Kalk
    • Mr.  PD Dr.  Dirk M.  Forner 
    • Buchforststr. 2
    • 51103  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
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    • Evangelisches Krankenhaus Kalk
    • Mr.  PD Dr.  Dirk M.  Forner 
    • Buchforststr. 2
    • 51103  Köln
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Evangelisches Krankenhaus Kalk
    • Mr.  Dr.  Dirk M.  Forner 
    • Buchforststr. 2
    • 51103  Köln
    • 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.