Trial document





This trial has been registered retrospectively.
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  DRKS00004657

Trial Description

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Title

The prevalence of HPV infection in patients with carcinoma of unknown primary site in head and neck region in Germany

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Infection with human papillomavirus (HPV) is linked to oropharyngeal cancer. This analysis
investigated possible associations between HPV status, smoking history and survival outcome in patients
with neck metastasis and carcinoma of unknown primary (CUP). p16 and HPV DNA will be analyzed in the lymph node metastasis

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Brief Summary in Scientific Language

Retrospective analysis of HPV status, smoking history and survival outcome in patients
with neck metastasis and carcinoma of unknown primary (CUP).

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Organizational Data

  •   DRKS00004657
  •   2015/02/12
  •   [---]*
  •   yes
  •   Approved
  •   PV3969, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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

  •   C80 -  Malignant neoplasm, without specification of site
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Interventions/Observational Groups

  •   Determination of p16 and HPV PCR in cervical lymph node metastasis (FFPE) and correlation to survival and smoking habits.
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Characteristics

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

HPV (human papillomavirus) and p16 status in cervical metastasis

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Secondary Outcome

overall survival, recurrent-free survival

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2012/07/09
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Cervical CUP-Syndrome without primary within 6 months after diagnosis.
paraffin-embedded tissue of the lymph node metastasis available.
>18 years.
patients informed consent.

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Exclusion Criteria

Primary tumor found within 6 months after diagnosis.
No paraffin-embedded tissue of the lymph node metastasis available.
<18 years.
No patients informed consent.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University Medical Center Hamburg-Eppendorf ENT,Head and Neck Department
    • Mr.  Prof. Dr. med.  Rainald  Knecht 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    • University Medical Center Hamburg-Eppendorf ENT,Head and Neck Department
    • Mr.  Prof. Dr. med.  Rainald  Knecht 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • University Medical Center Hamburg-Eppendorf ENT,Head and Neck Department
    • Mr.  Prof. Dr. med.  Rainald  Knecht 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • University Medical Center Hamburg-Eppendorf ENT,Head and Neck Department
    • Mr.  Prof. Dr. med.  Rainald  Knecht 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   HPV status in patients with head and neck of carcinoma of unknown primary site: HPV, tobacco smoking, and outcome. Silke Tribius et al. 2012
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* This entry means the parameter is not applicable or has not been set.