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

• Sponsor: Gazi University
• Collaborator: Tubitak
• Information provided by (Responsible Party): Nilgün Yılmaz Demirci, Gazi University

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
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

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

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

Contacts

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

Sponsors and Collaborators

Gazi University

Tubitak

Investigators

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

More Information

Publications:

Horváth I, Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, Becher G, van Beurden WJ, Corradi M, Dekhuijzen R, Dweik RA, Dwyer T, Effros R, Erzurum S, Gaston B, Gessner C, Greening A, Ho LP, Hohlfeld J, Jöbsis Q, Laskowski D, Loukides S, Marlin D, Montuschi P, Olin AC, Redington AE, Reinhold P, van Rensen EL, Rubinstein I, Silkoff P, Toren K, Vass G, Vogelberg C, Wirtz H; ATS/ERS Task Force on Exhaled Breath Condensate. Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J. 2005 Sep;26(3):523-48.

Dupont LJ, Dewandeleer Y, Vanaudenaerde BM, Van Raemdonck DE, Verleden GM. The pH of exhaled breath condensate of patients with allograft rejection after lung transplantation. Am J Transplant. 2006 Jun;6(6):1486-92.

Mo XD, Xu LP, Liu DH, Zhang XH, Chen H, Chen YH, Han W, Wang Y, Wang FR, Wang JZ, Liu KY, Huang XJ. Risk factors for bronchiolitis obliterans syndrome in allogeneic hematopoietic stem cell transplantation. Chin Med J (Engl). 2013 Jul;126(13):2489-94.

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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
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