Trial document




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  DRKS00006151

Trial Description

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Title

Clinicopathologic features of patients with solitary fibrous tumors of the pleura treated at the clinic for thoracic surgery at the University Hospital of Freiburg.

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Trial Acronym

SFTP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Solitary fibrous tumors are relatively rare neoplasms. They can occur anywhere in the human body, however the most common localisation is the thoracic cavity. In this case they are called solitary firbous tumors of the pleura (SFTP). To our current knowledge there are no certain criteria to whether a tumor acts maligne, meaning invasive growth, recurrence or metastasation. Due to its rare nature all current data is based on retrospekcive analysis of small groups. Certain immunohistochemical markers could be identified which are associated with malignant behavior of the tumors, however they do not always apply in the same way. The aim of this study is to analyze the patients treated at the Department of Thoracic Surgery at the Medical Center - University of Freiburg in the last decade and thus create further data on this rare neoplasm. A focus is put on certain cellular markers and their correlation with malignant behavior of the tumors and patient survival.

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Brief Summary in Scientific Language

Solitary fibrous tumors of the pleura(SFTP) are relatively rare neoplasms originating from submesothelial mesenchymal cells with a fibroblastic differentiation. They are often localized in the thoracal cavity but findings of tumors with similar histomorphologic features are described in many other locations. Our knowledge of the disease today is based mainly on monocentric retrospective data with small patient numbers. To date approximately 800 cases of SFTP are described in the literature. The biological behavior of SFTs is mostly benign, however about 15-20% show malignant properties with recurrence and or distant metastasis. There were different approaches to whether a SFTP is to be defined as malignant. Mostly used are the criteria by England et al. who suggested pathological features consisting of high mitotic activity high cellularity, necrosis and pleomorphism. De Perrot et al. used another approach and applied morphological features of the tumors for distinguation.
In this case series we analysed the Patients treated at the Medical Center - University of Freiburg with proven SFTP and their clinicopathologic data to generate further data of SFTPs with a focus on immunohistochemical markers, morphologic features and their predictive value for biological and clinical behavior of the tumors.

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Organizational Data

  •   DRKS00006151
  •   2014/06/04
  •   [---]*
  •   yes
  •   Approved
  •   251/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   Solitary fibrous tumor of the pleura
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Interventions/Observational Groups

  •   In patients with histologically proven solitary fibrous tumors immunohistochemical markers, morphologic features and their predictive value for biological and clinical behavior of the tumors will be analyzed.
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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

Correlation of immunhistochemic and morphologic properties of SFTP with survival, recurrence and metastasis

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Secondary Outcome

N/A

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/06/10
  •   25
  •   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

1. Adult patients with proven solitary fibrous tumor of the pleura
2. Treated at the Dept. of Thoracic Surgery from 2005 until 2013

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Mr.  Dr.  Severin  Schmid 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Mr.  Dr.  Severin  Schmid 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg - Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2014/10/01
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* This entry means the parameter is not applicable or has not been set.