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

NCT02318316 | Unknown

• 1 other identifier: EBC01
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exhaled Breath Condensate

Keywords

Exhaled breath condensate; allogeneic stem cell transplantation; pulmonary complications

Outcome Measures

Primary Outcomes (1)

• The pH level of exhaled breath condansate

  2 years

Secondary Outcomes (1)

• The nitrotyrosine and 8-isoprostane levels of exhaled breath condansate

  2 years

Study Arms (1)

EBC level

Exhaled breath condensate level of allogeneic stem cell transplantation patients

Other: Exhaled breath condensate

Interventions

Exhaled breath condensate OTHER

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

EBC level

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

allogeneic stem cell transplantation patients for hematologic malignancies and some benign hematological diseases

You may qualify if:

• hematologic malignancies or benign hematological diseases that allogeneic stem cell transplantation performed

You may not qualify if:

• allogeneic stem cell transplantation patients with Asthma or COPD

Sponsors & Collaborators

• Gazi University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Related Publications (3)

• 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.

  PMID: 16135737 BACKGROUND

• 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.

  PMID: 16686775 BACKGROUND

• 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.

  PMID: 23823823 BACKGROUND

Study Officials

• Zeki Yıldırım, professor

  Gazi University Faculty of Medicine Chest Disease Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilgün Yilmaz Demirci, MD

CONTACT

009031224143; nilgundemirci@gazi.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 17, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: December 17, 2014

Record last verified: 2014-12