Trial document





This trial has been registered retrospectively.
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  DRKS00009587

Trial Description

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Title

Analysis of biomarkers in the peripheral blood of patients with soft tissue sarcoma

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Soft tissue sarcoma is an aggressive malignancy of mesenchymal origin. This study examines the presence of the synovial sarcoma – specific SYT-SSX fusion transcript in microvesicles released by synovial sarcoma cells as well as its potential role as a biomarker for synovial sarcoma. Furthermore, miRNA-profiles in the peripheral blood of patients with synovial sarcoma are analyzed.

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Brief Summary in Scientific Language

Soft tissue sarcoma is an aggressive malignancy of mesenchymal origin. This study examines the presence of the synovial sarcoma – specific SYT-SSX fusion transcript in microvesicles released by synovial sarcoma cells as well as its potential role as a biomarker for synovial sarcoma.

Furthermore, miRNA-profiles in the peripheral blood of patients with synovial sarcoma are analyzed. Peripheral blood is withdrawn after obtaining patient consent at follow-up appointments. Total RNA is isolated and through the use of nested qPCR, nested PCR, qPCR and ddPCR, the detection of the tumor specific fusion gene is carried out. Furthermore, miRNA is isolated from whole blood cells and cell-free serum to generate tumor-specific miRNA profiles as a biomarker for synovial sarcoma.

Furthermore, an analysis of miRNA-profiles of patients with liposarcoma compared to healthy donors, patients with other benign tumors (lipomas) and patients with other sarcoma subtypes as well as an analysis of cell-specific micorvesicles as biomarkers for soft tissue sarcoma is carried out.

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Organizational Data

  •   DRKS00009587
  •   2015/11/13
  •   [---]*
  •   yes
  •   Approved
  •   343/13, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   C49.9 -  Malignant neoplasm: Connective and soft tissue, unspecified
  •   C41.9 -  Malignant neoplasm: Bone and articular cartilage, unspecified
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Interventions/Observational Groups

  •   Detection of the SYT-SSX- fusion gene in the peripheral blood of patients with synovial sarcoma / Analysis of miRNA-profiles in the peripheral blood of patients with synovial sarcoma
  •   Analysis of miRNA-profiles in the peripheral blood of patients with soft tissue sarcoma (different subtypes), healthy donors/donors without medical disorders and patients with benign tumors (Lipomas)
  •   Analysis of cell-specific microvesicles in the peripheral blood of patients with soft tissue sarcoma pre- and postoperatively and in comparison to healthy donors.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Detection of the SYT-SSX fusion gene as biomarker for synovial sarcoma

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Secondary Outcome

Analysis of miRNA-profiles of patients with synovial sarcoma compared to healthy donors and patients with other sarcoma subtypes. Analysis of miRNA-profiles of patients with liposarcoma compared to healthy donors, patients with other benign Tumors (lipomas) and patients with other sarcoma subtypes. Analysis of micorvesicles as biomarkers for soft tissue sarcoma.


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/01/31
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   99   Years
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Additional Inclusion Criteria

synovial sarcoma, liposarcoma, Ewing sarcoma. myxoid malignant fibrous histiocytoma, leiomyosarcoma, extraskeletal myxoid chondrosarcoma, pleomorphic/undifferentiated sarcoma, myxoid fibrosarcoma, spindle-cell sarcoma, malignant peripheral nerve sheath Tumor, intimal sarcoma of the pulmonal artery

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Exclusion Criteria

other malignancies

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Mr.  PD Dr.  Steffen  Eisenhardt 
    • Hugstetter Strasse 55
    • 79110  Freiburg
    • Germany
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    •   +49 761/270-24010
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    • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Plastische und Handchirurgie
    • Mr.  Dr.  David   Braig 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURG Klinik für Plastische und Handchirurgie
    • Mr.  Dr.  David  Braig 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Forschungskommission Freiburg
    • Elsässer Str. 2m
    • 79110  Freiburg
    • Germany
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    •   +49 761/270-84670
    •   +49 761/270-84670
    •   [---]*
    •   [---]*
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    • Fördergesellschaft Forschung Tumorbiologie - Liquid Biopsy Initiative
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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