Trial document





This trial has been registered retrospectively.
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  DRKS00009521

Trial Description

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Title

Detection of tumor specific changes in nucleic acids in body fluids of patients
with malignancies

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Current methods for diagnosis, course evaluation and follow-up of Neoplastic diseases such as imaging or conventional tumor markers have a low sensitivity and specificity. When tumors are found in the majority of Cases genetic changes such as mutations in oncogenes or the change in the xpression of genes that have predictive and prognostic significance, but not yet be used as a follow-up parameters for the response of a tumor disease can, as opposed to blood cancer these genetic changes with conventional Methods can not be measured in the blood or even quantified. It is known that Tumor cells continuously small amounts of DNA and RNA release into the blood circulation. Samit it has become possible to tumor-specific genetic changes in nucleic acids detectable in blood samples and quantified. We could show in preliminary work that in gastrointestinal stromal tumor specific mutations detected in plasma samples can be correlated and the amount thereof with the clinical course. For the Research projects qualify patients with a tumor disease, for from the Examination of the tumor tissue tumor-specific genetic alterations are known. The aim of the project is proposed here, in blood samples from patients with tumors corresponding tumor-specific changes such as somatic mutations, DNA Methylation profiles or miRNA profiles in body fluids such as whole blood, blood plasma, urine, Saliva, etc. to identify and to quantify, and to correlate these results with traditional methods of assessment of the course as imaging or conventional Tumor markers. The aim is the use of tumor-specific mutations in body fluids, such as circulating tumor DNA in the blood as a predictive and prognostic biomarkers.

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Brief Summary in Scientific Language

Current methods for diagnosis, course evaluation and follow-up of Neoplastic diseases such as imaging or conventional tumor markers have a low sensitivity and specificity. When tumors are found in the majority of Cases genetic changes such as mutations in oncogenes or the change in the xpression of genes that have predictive and prognostic significance, but not yet be used as a follow-up parameters for the response of a tumor disease can, as opposed to blood cancer these genetic changes with conventional Methods can not be measured in the blood or even quantified. It is known that Tumor cells continuously small amounts of DNA and RNA release into the blood circulation. Samit it has become possible to tumor-specific genetic changes in nucleic acids detectable in blood samples and quantified. We could show in preliminary work that in gastrointestinal stromal tumor specific mutations detected in plasma samples can be correlated and the amount thereof with the clinical course. For the Research projects qualify patients with a tumor disease, for from the Examination of the tumor tissue tumor-specific genetic alterations are known. The aim of the project is proposed here, in blood samples from patients with tumors corresponding tumor-specific changes such as somatic mutations, DNA Methylation profiles or miRNA profiles in body fluids such as whole blood, blood plasma, urine, Saliva, etc. to identify and to quantify, and to correlate these results with traditional methods of assessment of the course as imaging or conventional Tumor markers. The aim is the use of tumor-specific mutations in body fluids, such as circulating tumor DNA in the blood as a predictive and prognostic biomarkers.

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Organizational Data

  •   DRKS00009521
  •   2016/04/05
  •   [---]*
  •   yes
  •   Approved
  •   126/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   all types of tumor
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Interventions/Observational Groups

  •   Detection of tumor specific changes in nucleic acids in body fluids
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Characteristics

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

Proportion of patients with malignant disease and a known tumor-specific , genetic
Change detection with the corresponding genetic modification in a
Body fluid such as blood, plasma, saliva or urine

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Secondary Outcome

- Correlation of detection of tumor-specific , genetic alterations in
Body fluids with the clinical course ( imaging : recurrence , response ) and
clinical endpoints
- Correlation of detection of tumor-specific , genetic alterations in
Body fluids with clinical endpoints (progressionfree- and overall survival )

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/10/22
  •   1000
  •   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

none

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med.  Nikolas  von Bubnoff 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med.  Nikolas  von Bubnoff 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • 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.