Trial document





This trial has been registered retrospectively.
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  DRKS00004515

Trial Description

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Title

Therapy of neoplasms of the maxilla

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Trial Acronym

NeMa

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URL of the Trial

http://keine vorgesehen

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Brief Summary in Lay Language

Background:
Malignant tumors of the maxilla show at diagnosis usually advanced tumor stages. The cancer grows initially with only a few symptoms. Despite continuous advances in diagnosis and treatment, these patients have a relatively bad prognosis.

Aim:
The aim of this study is to summarize different diagnosis, treatments and results in the treatment of patients with malignant tumors.

Questions:
How many people with cancer of the maxilla were treated for the first time at the University Hospital in Freiburg between the years of 1995 and 2010? How was the tumor classified and treated? Which posttreatment quality of life could be achieved again?

hypotheses:
Relationship between tumor and survival

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Brief Summary in Scientific Language

The aim of the study is the diagnosis, treatment and the survival rate of patients with malignant tumors.
The data put various patient-related parameters such as age, gender, risk group, family history, and possible pre-existing conditions before the diagnosis in the context. The primary hypothesis is that differences between the types of tumors in terms of the survival rate are available. The collective includes patients who were treated from 1995 to 2010 primarily in the Department of Oral and Maxillofacial Surgery at the University Hospital Freiburg.

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Organizational Data

  •   DRKS00004515
  •   2012/12/06
  •   [---]*
  •   yes
  •   Approved
  •   381/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   C05 -  Malignant neoplasm of palate
  •   C06 -  Malignant neoplasm of other and unspecified parts of mouth
  •   C03 -  Malignant neoplasm of gum
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Interventions/Observational Groups

  •   Patients with different malignant tumors of the midface are compared within the treatment, the quality of life and the survival rate are calculated.
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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

The data from the medical records are acquired one-time retrospective with a registration sheet on 30.10.2012.The data related to age, sex, therapy, posttreatment symptoms and survival of these patients.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/30
  •   119
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Therapy between the years 1995 until 2010 in ZMK Freiburg, diagnosis and primary therapy: neoplasms of the maxilla or palate, base of the skull or nose sinuses

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Exclusion Criteria

- Tumors with malignant skin structure
- benign tumor
- second-therapy
- malignant tumors of the tongue, floor of mouth, mandible

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Addresses

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    • Universitätsklinikum Freiburg, Abteilung für Mund-Kiefer-Gesichtschirurgie
    • Mr.  Dr.  Pit  Voss 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung für Mund-Kiefer-Gesichtschirurgie
    • Mr.  Dr.  Pit  Voss 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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    • Uniklinikum Freiburg
    • Ms.  ZÄ  Ulrike  Markmann 
    • Fehrenbachallee 19
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Abteilung für Mund-Kiefer-Gesichtschirurgie
    • Mr.  Dr.  Pit  Voss 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/01
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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.