Trial document




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  DRKS00006883

Trial Description

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Title

Pilot study to analyze the exhalation profile of patients with graft versus host disease (GvHD) of the lung after allogeneic stem cell transplantaion

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Trial Acronym

GvHD exhalate

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Complications after stem cell transplantation affecting the lung are feared. Thus, the mortality risk is increased in this case by 15-fold to normal. In addition to infections and incompatibilities of drugs (immunosuppressants), the graft-versus-host disease (GVHD) plays a crucial role. There are difficulties in accurately diagnose. Only invasive measures such as lavage or histology are available, which are risky feasible in this patient group. On the other hand, early diagnosis is important to prevent an irreversible deterioration. The breath condensate analysis is a tool for the investigation of change in lung, which is simple and riskless for the patient. The aim of this research project is to examine whether it is possible in patients with lung GVHD to analyse specific properties such as pH, or specific protein like inflammatory cytokines. For this purpose, initially, a comparison of patients with and without pulmonary GVHD should be performed.

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Brief Summary in Scientific Language

Pulmonary complications of allogeneic stem cell transplant patients are among the most feared complications. So in this case the risk of mortality is increased due to pulmonary dysfunction to the 15-fold. This is caused by pulmonary infections, toxicities caused by pretreatment, conditioning before transplantation and side effects of immunosuppressive drugs. A accurate diagnosis of GVHD is difficult, because of the non-specific changes in pulmonary function tests and HR-CT. Invasive measurements like bronchio alveolar lavage or histology are necesserary to get the diagnosis of GVHD. This subsequently increases the risk in these patients. On the other hand, an early diagnosis of GVHD is important since it is proven that early treatment can avoid an irreversible deterioration in patients conditions.
The breath condensate analysis is a simple non invasive tool for the investigation of a pulmonary changes or inflammatory processes which is riskless for the patient.
The aim of this research project is to investigate, whether in patients with pulmonary GVHD-the exhaled breath condensate (pH, specific protein meadurements) could be an feasable diagnostic approach to detect early GVHD. For this purpose, a comparison of patients with and without Lung GVHD should be performed.

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Organizational Data

  •   DRKS00006883
  •   2015/01/27
  •   [---]*
  •   yes
  •   Approved
  •   174/09, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   T86.00 -  [generalization T86.0: Bone-marrow transplant rejection]
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Interventions/Observational Groups

  •   pulmonary GVHD:
    One-time execution of ENose and IMS measurement and one blood sampling
  •   no pulmonary GVHD:
    One-time execution of ENose and IMS measurement and one blood sampling
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Differences in breath condensate

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Secondary Outcome

1 protein concentration in blood
2. volatile organic compounds measured with IMS and eNose

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/01/06
  •   50
  •   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

Review Group (V.A. lung GvHD):
-Z.n. allogeneic stem cell or bone marrow transplantation
-a GVHD of the lung is assumed by:
> respiratory symptoms
> Change in lung function e.g. FEV1 <75% FEV1 / VCin <0.7, signs of air trapping (RV> 120%),
> Exclusion of infectious complications by CT thorax (clinical routine / no study examination), laboratory diagnostics (CRP, PCT), infectiological diagnosis (CMV PCR, blood culture, sputum, if necessary)
> CT morphological suspicion by wall thickening of the small airways or bronchiectasis
> after clinic exclusion of cardiac causes (ECG and UKG)
> if necessary. other manifestations of GVHD

comparison group
-Z.n. allogeneic stem cell or bone marrow transplantation
-not respiratory symptoms
-Agreement to study participation

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Exclusion Criteria

Review Group (V.A. lung GvHD):
- Infectious or cardiopulmonary causes pulmonary symptoms. Exclusion by chest CT, inflammation paramters (CRP, PCT), possibly microbiological diagnosis, ECG and UKG

comparison group:
- Clinical or imaging evidence of pulmonary disease (GvHD, infections, cardiopulmonary disease) in the month prior to the examination

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Addresses

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    • Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Germany, Member of the German Center for Lung Research (DZL)
    • Mr.  PD Dr. med.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Germany, Member of the German Center for Lung Research (DZL)
    • Mr.  PD Dr. med.  Andreas Rembert  Koczulla 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Universitätsklinikum Giessen und Marburg Innere Medizin, Pneumologie
    • Ms.  Ursula  Boas 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Gießen und Marburg, Standort Marburg
    • Baldingerstraße
    • 35033  Marburg
    • 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.