Trial document




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  DRKS00010048

Trial Description

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Title

Etiology, prognostic factors and quality of life in patients with carcinomas of the major salivary glands

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Malignancies of the major salivary glands are various cancers with different treatments. Therapy, follow-up, prognosis and influence on quality of life are different. Especially in cancer of the parotid gland the function of the facial nerve is affected by tumor or therapy causing function or aesthetic problems. Additionally resection of a salivary gland or head and neck radiation therapy may cause a xerostomia. The main part of our study is a combined questionnaire (University of Washingtion quality of life questionnaire, and questionnaires evaluation facial nerve function and xerostomia).

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Brief Summary in Scientific Language

Malignancies of the major salivary glands are various cancers with different treatments. Therapy, follow-up, prognosis and influence on quality of life are different. Especially in cancer of the parotid gland the function of the facial nerve is affected by tumor or therapy causing function or aesthetic problems. Additionally resection of a salivary gland or head and neck radiation therapy may cause a xerostomia. The main part of our study is a combined questionnaire (University of Washingtion quality of life questionnaire, and questionnaires evaluation facial nerve function and xerostomia).

Many studies evaluated the pathogenesis and outcome of salivary gland cancer. In contrast the influence on the health-related quality of life was hardly evaluated.

Initially we planned a retrospective analysis of all patients diagnosed with salivary gland carcinoma between 2002 and 2015. Due to the encouraging results of these patients recruitment was extended.

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Organizational Data

  •   DRKS00010048
  •   2016/02/16
  •   [---]*
  •   yes
  •   Approved
  •   573/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   C07 -  Malignant neoplasm of parotid gland
  •   C08.0 -  Malignant neoplasm: Submandibular gland
  •   C08.1 -  Malignant neoplasm: Sublingual gland
  •   C08.8 -  Malignant neoplasm: Overlapping lesion of major salivary glands
  •   C08.9 -  Malignant neoplasm: Major salivary gland, unspecified
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Interventions/Observational Groups

  •   Patients with former carcinoma of the major salivary glands will be interviewed once using a combined quality of life questionnaire
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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

Evaluating data concerning tumor characteristics and quality of life

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Secondary Outcome

N/A

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/02/22
  •   100
  •   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

Patients (male & female) with primary diagnosis of a carcinoma of the major salivary glands treated in our clinic between 2005 and 2017.

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Exclusion Criteria

N/A

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Mr.  Dr. med.  Christoph  Becker 
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Mr.  Dr. med.  Christoph  Becker 
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
    • Mr.  Dr. med.  Christoph  Becker 
    • Killianstraße 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/07/07
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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.