Trial document




drksid header

  DRKS00010117

Trial Description

start of 1:1-Block title

Title

Differential Protein and Gene Expression in Endocrine and Neuroendocrine Tumors (NET)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Molecular pathology in NET

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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 (neuro)endocrine tumors/tissues and their metastases in liver and fatty tissues. 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. The spectrum of planned experimental methods comprises molecular genetics, proteomics, immunohistochemistry, generation of primary tissue cultures and murine xenografts.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010117
  •   2016/03/14
  •   [---]*
  •   yes
  •   Approved
  •   837.120.15 (9888), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C17 -  Malignant neoplasm of small intestine
  •   D44 -  Neoplasm of uncertain or unknown behaviour of endocrine glands
  •   C75 -  Malignant neoplasm of other endocrine glands and related structures
  •   C25.4 -  Malignant neoplasm: Endocrine pancreas
  •   D35 -  Benign neoplasm of other and unspecified endocrine glands
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Quantitative Expression Analysis of the proteom and gene Expression of Primary Tumor, normal tissue, and metastases
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Disease associated Proteins and Genes

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Identification of markers with prognostic significance

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/02/29
  •   1000
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients who underwent surgery due to (neuro)endocrine tumors

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

//

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsmedizin Mainz, Sektion Endokrine Chirurgie, Klinik für Allgemein-, Viszeral- u. Transplantationschirurgie
    • Mr.  Univ.-Prof. Dr. med.  Thomas J.  Musholt 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsmedizin Mainz, Sektion Endokrine Chirurgie, Klinik für Allgemein-, Viszeral- u. Transplantationschirurgie
    • Mr.  Univ.-Prof. Dr. med.  Thomas J.  Musholt 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsmedizin Mainz, Sektion Endokrine Chirurgie, Klinik für Allgemein-, Viszeral- u. Transplantationschirurgie
    • Mr.  Univ.-Prof. Dr. med.  Thomas J.  Musholt 
    • Langenbeckstr. 1
    • 55131  Mainz
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.