Trial document




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  DRKS00010141

Trial Description

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Title

Molecular Pathology of Benign and Malignant Thyroid Tumors

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Trial Acronym

Thyroid Molecular Pathology

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The retrospective and prospective basic research study is carried out with excess tissues at disposal after surgery of patients with thyroid tumors/tissues and their lymph node and distant metastases. Indications comprise oncology, general endocrinology as well as metabolic disorders such as diabetes type 2, metabolic syndrome and obesity. Clinical data will be correlated with results of molecular pathology analyses. Experimental methods planned comprise molecular genetics, proteomics, immunohistochemistry, and potentially generation of primary tissue cultures and murine xenografts.

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Organizational Data

  •   DRKS00010141
  •   2016/03/15
  •   [---]*
  •   yes
  •   Approved
  •   Substudie zu 837.120.15 (9888), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   C73 -  Malignant neoplasm of thyroid gland
  •   D35 -  Benign neoplasm of other and unspecified endocrine glands
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Interventions/Observational Groups

  •   Retrospective and prospective basic research study on excess tissues at disposal after surgery of patients with thyroid tumors/tissues and their lymph node and distant metastases; molecular pathology analyses (molecular genetics, proteomics, immunohistochemistry, and potentially generation of primary tissue cultures and murine xenografts).
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Characteristics

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

Identification of disease-associated genes as well as expression of genes and proteins

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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
  •   2016/02/29
  •   800
  •   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

Patients who underwent surgery for benign and malignant thyroid tumors (or C-cell hyperplasia)

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Exclusion Criteria

[---]*

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Addresses

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz, Sektion Endokrine Chirurgie, Klinik für Allgemein-, Viszeral- u. Transplantationschirurgie
    • Mr.  Univ.-Prof. Dr. med.  Thomas J.  Musholt 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz, Sektion Endokrine Chirurgie, Klinik für Allgemein-, Viszeral- u. Transplantationschirurgie
    • Mr.  Univ.-Prof. Dr. med.  Thomas J.  Musholt 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Mainz, Sektion Endokrine Chirurgie, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
    • Mr.  Univ.-Prof. Dr. med.  Thomas J.  Musholt 
    • Langenbeckstr. 1
    • 55131  Mainz
    • 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.