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

NCT ID: NCT02318316

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Exhaled Breath Condensate

Keywords

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Exhaled breath condensate allogeneic stem cell transplantation pulmonary complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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EBC level

Exhaled breath condensate level of allogeneic stem cell transplantation patients

Exhaled breath condensate

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Nilgün Yılmaz Demirci

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeki Yıldırım, professor

Role: PRINCIPAL_INVESTIGATOR

Gazi University Faculty of Medicine Chest Disease Department

Central Contacts

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Nilgün Yilmaz Demirci, MD

Role: CONTACT

Phone: 009031224143

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 16135737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16686775 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23823823 (View on PubMed)

Other Identifiers

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EBC01

Identifier Type: -

Identifier Source: org_study_id