Trial document





This trial has been registered retrospectively.
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  DRKS00010587

Trial Description

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Title

Evaluation of IL-6 and IL-8 as prognostic markers after local ablation therapy of breast or abdominal lesions (ESTIMATE)

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Trial Acronym

ESTIMATE

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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

Pretherapeutic serum concentrations of IL-6 and IL-8 have a prognostic value for overall survival of patients receiving local ablation therapy for breast or abdominal tumors.

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Organizational Data

  •   DRKS00010587
  •   2019/05/23
  •   [---]*
  •   yes
  •   Approved
  •   91/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   RAD302  (internes Register)
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Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C20 -  Malignant neoplasm of rectum
  •   Indication for local ablative therapy of malignancies
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Interventions/Observational Groups

  •   Parameters such as IL-6 and IL-8 following locally ablative therapy as the radioembolization prognostic value for overall survival have not been studied.
    Evaluating the valence of IL-6 and IL-8 should be the goal of the study.

    Patients with lung tumors or liver tumors undergoing image-guided local therapy (HDR brachytherapy in the afterloading procedure (HDR), radiofrequency ablation (RFA) or microwave ablation (MWA)) will be taken for pre-therapeutic blood sampling. Parameters like IL-6 and IL-8 are determined at the end of the recruitment period.
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Characteristics

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

Evaluation of pre-treatment IL-6 and IL-8 concentration as prognostic marker for overall survival after image-guided therapy lokalablativer (HDR, MWA, RFA) intrathoracic or intra-abdominal malignancies.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/07/18
  •   800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• primary or secondary metastsis of lungs-cancer and HCC.
• male or female, > 18 years
• Indication of HDR brachytherapy, microwave ablation or radiofrequency ablation in one or more sessions
• Patient confirms all study procedures (taking blood sample like routine diagnostics)
• Signed informed consent

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Exclusion Criteria

• contraindication for local ablative therapies
Life expectancy <3 months

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Addresses

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    • Klinikum der Universität München, Campus Großhadern
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Klinikum der Universität München, Klinik und Poliklinik für Radiologie, LMU
    • Mr.  Dr. med.  Sergio Roman  Grosu 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    • Universitätsklinikum MagdeburgKlinik für Radiologie und Nuklearmedizin
    • Mr.  Dr. med.  Maciej  Powerski 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
    • Mr.  Prof.  Jens  Ricke 
    • Marchioninistr. 15
    • 81377  München
    • Germany
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    •   (089) 4400-4400 72750
    •   [---]*
    •   [---]*
    •   [---]*
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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.