Clinical trial NCT02318316: "Exhaled Breath Condensate" in Allogeneic Stem Cell Recipients and the Value in Follow-up
Official title: "Exhaled Breath Condensate" in Allogeneic Stem Cell Recipients and Value in Follow-up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exhaled Breath Condensate
Keywords: Exhaled breath condensate
allogeneic stem cell transplantation
pulmonary complications
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2014-12-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: allogeneic stem cell transplantation patients for hematologic malignancies and some benign hematological diseases

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.


Eligibility 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

Primary outcomes:
measure: The pH level of exhaled breath condansate
timeFrame: 2 years
Secondary outcomes:
measure: The nitrotyrosine and 8-isoprostane levels of exhaled breath condansate
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University Faculty of Medicine Chest Disease Department
name: Zeki Yıldırım, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horvath 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, Jobsis 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. doi: 10.1183/09031936.05.00029705.
citation: 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. doi: 10.1111/j.1600-6143.2006.01331.x.
citation: 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.