Trial document




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  DRKS00014018

Trial Description

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Title

Identfication of tumor-specific and tumor-associated antigens for potential clinical application in vaccination studies - Part: Squamous cell cancer of the head and neck

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Cancer develops through uncontrolled growth of cells of a different origin. To this end, many changes of genetic information, cell metabolism and immune interactions have to develop. In this regard, genetic mutations can lead to alterations of cellular metabolism leading to production of proteins which are not occurring in non-malignant tissue. The immune system can regognize such structures and specifically attack tumor cells.
This study aims at the direct identification of these tumor-specific and/or tumor-associated antigens comparing cancer- and non-malignant tissue. In future clinical trials, the identified structured could be used for stimulation of a tumor-specific immune response.

Study participants:
30 patients with confirmed diagnosis of head and neck squamous cell carcinoma and indication for surgical resection.

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Brief Summary in Scientific Language

During malignant transformation, tumor cells develop multiple alteration in genetic information, cell proliferation, metabolism and adhesion. These alterations result in aberrant expression of HLA-restricted tumor-associated and/or tumor-specific antigens which can be recognized by the immune system. This recognition does not lead to sufficient rejection of established tumors. This study aims to identify immunologically relevant target structures which can be utilized in future clinical vaccine trials.

Study participants:
30 patients with confirmed diagnosis of head and neck squamous cell carcinoma and indication for surgical resection.

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Organizational Data

  •   DRKS00014018
  •   2018/02/14
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  •   yes
  •   Approved
  •   222/2015BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

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

  •   Patient with squamous cell cancer of the head and neck with indication for surgical resection.
    Tumor- and adjacent non-malignant material, as well as peripheral blood are obtained for laboratory analyses (HLA ligandome, exome, transcriptome, evalutation of antigen-specific T cells in ELISpot and intracellular cytokine staining).
  •   Control group for the evaluation of antigen-specific T cells only: Patient with squamous cell carcinoma of the head and neck without indication for surgical intervention or small tumors.
    Cave: No tumor and non-malignant tissue is obtained.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Identification of HLA-presented tumor-associated and/or tumor-specific ligands (HLA-ligandome)

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Secondary Outcome

- Evaluation of the immunological relevance of the identified ligands
- Evaluation of metabolic pathways

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/01/15
  •   60
  •   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

Squamous cell carcinoma of the head and neck with indication for surgical resection

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Exclusion Criteria

- Relevant comorbidities
- no indication for surgery
- insufficient amount of tumor material

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Addresses

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Sources of Monetary or Material Support

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    • Europäische Union
    • Brüssel
    • Belgium
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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.