"Exhaled Breath Condensate" in Allogeneic Stem Cell Recipients and the Value in Follow-up

Sponsor
Gazi University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02318316
Collaborator
The Scientific and Technological Research Council of Turkey (Other)
80
16

Study Details

Study Description

Brief Summary

The most effective treatment of hematologic malignancies and some benign hematological diseases is allogeneic stem cell transplantation therapy. Pulmonary complications can occur after allogeneic stem cell transplantation. And these complications effect mortality and morbidity in these patients. In this study we want to investigate the use of exhaled breath condensate (EBC) collection which is a simple and completely noninvasive method. By this way we hope to detect pulmonary complications early. EBC, has been implicated in the pathophysiology of inflammatory airway diseases such as cystic fibrosis, asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis. EBC, has not been investigated before in patients who underwent stem cell transplantation.

Condition or Disease Intervention/Treatment Phase
  • Other: Exhaled breath condensate

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
"Exhaled Breath Condensate" in Allogeneic Stem Cell Recipients and Value in Follow-up
Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
EBC level

Exhaled breath condensate level of allogeneic stem cell transplantation patients

Other: Exhaled breath condensate
Breath condensate samples will be collected with a commercially available condenser (EcoScreen®, Erich Jaeger, Germany). Subjects will breathe through a mouthpiece and a two-way non-rebreathing value in which inspiratory and expiratory air were separated, and saliva was trapped. They will be asked to breathe at a normal frequency and tidal volume for 15 minutes while wearing nose clips, allowing collection of 1.5-2.5 mL of condensate. After collecting this, pH will be measured and the waste collection will be stored at -80 degrees. Then 8 isoprostane and nitrotyrosine will be measured collectively

Outcome Measures

Primary Outcome Measures

  1. The pH level of exhaled breath condansate [2 years]

Secondary Outcome Measures

  1. The nitrotyrosine and 8-isoprostane levels of exhaled breath condansate [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • hematologic malignancies or benign hematological diseases that allogeneic stem cell transplantation performed
Exclusion Criteria:
  • allogeneic stem cell transplantation patients with Asthma or COPD

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gazi University
  • The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Zeki Yıldırım, professor, Gazi University Faculty of Medicine Chest Disease Department

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nilgün Yılmaz Demirci, MD, Gazi University
ClinicalTrials.gov Identifier:
NCT02318316
Other Study ID Numbers:
  • EBC01
First Posted:
Dec 17, 2014
Last Update Posted:
Dec 17, 2014
Last Verified:
Dec 1, 2014
Keywords provided by Nilgün Yılmaz Demirci, MD, Gazi University

Study Results

No Results Posted as of Dec 17, 2014