Trial document




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  DRKS00009641

Trial Description

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Title

Effect of Bardoxolon-Methyl on formation, extent and persistence of in vitro induced DNA damage in human peripheral blood lymphocytes.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We will analyze,iif the agent Bardoxolone-Methyl has a protective effect on irradiated human cells.

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Brief Summary in Scientific Language

Triterpenoide have anti-inflammatory, -oxidative, -proliferative,-cancer and -carcinogenic features. Bardoxolone-Methyl (CDDO-Me) is a semi-synthetic triterpenoid acting as an activator of the Nrf2-pathway and as an inhibitor of the NFkappaB-pathway. This modulation of cellular processes induces a variety of cellular effects with clinical benefit. CDDO-Me has radioprotective properties duo to the imoprovement of DNA-repair and cell survivel. Therefore and due to the good tolerance and easy applicability, CDDO-ME is a candidate for a radioprotective agent for clinical use. If CDDO-Me is effective even after radiation exposure, it would be possible to apply the agent e.g. after an accidental exposure for therapy of radiation accident victims.
The objective of the study is to examine in vitro the CDD-Me-mediatied effects after radiation exposure (X-rays) using humen peripheral blood lymphocytes (CDDO-Me application after and before irradiation). Radiation induced effects and their potential modulation is analysed by three cytogenetic methods: 1. Analysis of dicentric chromosomes, 2. Anylsis of translocations by FISH, 3. Analysis of Micronuclei including analysis of apoptosis by flow cytometry.

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Organizational Data

  •   DRKS00009641
  •   2015/12/08
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  •   yes
  •   Approved
  •   250/15, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   radiation damage: in vitro lymphocytes
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Interventions/Observational Groups

  •   After venipuncture human peripheral blood is incubated with Bardoxolone. At different time points after addition of Bardoxolone (2h, 6, 30 min) or before (30 min) the blood is exposed against X-rays. Using cytogenetic techniques the radiation induced DNA damage will be detected. A Bardoxolone-induced modulation of the DNA damage will be detected.
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Characteristics

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

IN VITRO analysis of radiation-induced DNA-damage : symmetrical chromsomsomal translocations in peripheral blood lymphocytes (FISH) and asymmetrical translocations (DCA).

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Secondary Outcome

IN VITRO analysis of radiation-induced DNA-damage (micronucleus formation) in peripheral blood lymphocytes (CBMN). Apoptosis using flow cytometry.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2015/12/07
  •   3
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

no previous radiation therapy/diagnostics (last 2 years)

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Exclusion Criteria

previous radiation therapy/diagnostics (2 years)

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Addresses

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    • Institut für Radiobiologie der Bundeswehr (zugehörig: Bundesministerium der Verteidigung)
    • Neuherbergstraße 11
    • 80937  München
    • Germany
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    • Institut für Radiobiologie der Bundeswehr
    • Ms.  Dr.  Christina  Beinke 
    • Neuherbergstraße 11
    • 80937  München
    • Germany
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    • Institut für Radiobiologie der Bundeswehr
    • Ms.  Dr.  Christina  Beinke 
    • Neuherbergstraße 11
    • 80937  München
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Radiobiologie der Bundeswehr, zugehörig: Bundesministerium der Verteidigung -
    • Neuherbergstraße 11
    • 80937  München
    • Germany
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Status

  •   Recruiting planned
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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.