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

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ClinicalTrials.gov Identifier: NCT02318316
Recruitment Status : Unknown
Verified December 2014 by Nilgün Yılmaz Demirci, Gazi University.
Recruitment status was:  Not yet recruiting
First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Sponsor:
Collaborator:
Tubitak
Information provided by (Responsible Party):
Nilgün Yılmaz Demirci, Gazi University

Study Description
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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
Exhaled Breath Condensate Other: Exhaled breath condensate

Study Design
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Study Type : Observational
Estimated 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 : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : April 2016
Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. The pH level of exhaled breath condansate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The nitrotyrosine and 8-isoprostane levels of exhaled breath condansate [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
allogeneic stem cell transplantation patients for hematologic malignancies and some benign hematological diseases
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318316


Contacts
Contact: Nilgün Yilmaz Demirci, MD 009031224143 nilgundemirci@gazi.edu.tr

Sponsors and Collaborators
Gazi University
Tubitak
Investigators
Principal Investigator: Zeki Yıldırım, professor Gazi University Faculty of Medicine Chest Disease Department
More Information
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Publications:

Responsible Party: Nilgün Yılmaz Demirci, MD, Gazi University
ClinicalTrials.gov Identifier: NCT02318316     History of Changes
Other Study ID Numbers: EBC01
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by Nilgün Yılmaz Demirci, Gazi University:
Exhaled breath condensate
allogeneic stem cell transplantation
pulmonary complications