Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012947

Trial Description

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Title

Examination, validation and translation of signaling networks of cellular radiation response

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Trial Acronym

ZiSStrans

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This research is conducted to establish if the occurrence of oral mucositis and xerostomia due to reduced salivation during therapy is caused by differences in the radiation sensitivity of mucosal cells and / or by differences in the composition of saliva (protein components).

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Brief Summary in Scientific Language

Tumor patients undergoing regular radiation therapy are examined for the manifestation of side effects (radiogenic mucositis and xerostomia), additional clinical parameters are collected from existing medical records, and samples of saliva, serum and full blood are collected and stored for marker examinations. In addition, before radiation therapy a single biopsy of oral mucosa is collected to investigate patient-specific cellular radiation sensitivity (colonisation, proliferation, migration).

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Organizational Data

  •   DRKS00012947
  •   2019/06/04
  •   [---]*
  •   yes
  •   Approved
  •   413/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   C10 -  Malignant neoplasm of oropharynx
  •   C13 -  Malignant neoplasm of hypopharynx
  •   C32 -  Malignant neoplasm of larynx
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Interventions/Observational Groups

  •   Collecting clinical patient data; Oral Mucositis Assessment; oral mucosa biopsy; samples of resting saliva and sample of serum before radiochemotherapy; preparation of biological materials: proteome analysis of saliva, cell culture of keratinocytes, in vitro testing of radiation sensitivity, microRNA analyses of serum samples
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Characteristics

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

Prediction of individual, i.e. patient-specific side effects and tumor control during / after radiation therapy

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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
  •   2017/09/01
  •   150
  •   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

Histologically confirmed carcinoma of the oral cavity, the oropharynx, hypopharynx or larynx; planned radiation therapy in the head-neck-area according to a standardized protocol (cisplatin-based radiochemotherapy, radiation dose 60-70 Gy, fractionation 5 x 2 Gy / week); written consent

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Exclusion Criteria

Complete removal of major salivary glands in the context of surgical tumor therapy

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Addresses

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof. Dr. med.  Anca Ligia  Grosu 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Prof. Dr. med.  Michael  Henke 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Dr.  Elsa Beatriz  Monroy Ordonez 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Bonn
    • Heinemannstr. 2
    • 53175  Bonn
    • 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.