CClinicalTrials.gg
Sign In
Status unknownNCT02318316Updated Dec 17, 2014

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

An observational study in Exhaled Breath Condensate, sponsored by Gazi University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-12-17.

Sponsored by Gazi University · Observational

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Exhaled Breath Condensate

Keywords

  • Exhaled breath condensate
  • allogeneic stem cell transplantation
  • pulmonary complications
03

In context

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • allogeneic stem cell transplantation patients with Asthma or COPD
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • EBC level

    Exhaled breath condensate level of allogeneic stem cell transplantation patients

    Other: Exhaled breath condensate

Interventions

  • OtherExhaled 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

06

What researchers measure

Primary outcomes

  1. The pH level of exhaled breath condansate

    Time frame: 2 years

Secondary outcomes

  1. The nitrotyrosine and 8-isoprostane levels of exhaled breath condansate

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 16135737 ↗
  • 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. PubMed 16686775 ↗
  • 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. PubMed 23823823 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02318316
Lead sponsor
Gazi University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Nilgün Yılmaz Demirci (MD, Gazi University) — Principal investigator
First posted
Dec 17, 2014
Start date
Dec 2014
Primary completion
Dec 2015 (estimated)
Completion
Apr 2016 (estimated)
Last update
Dec 17, 2014

Study contacts

Nilgün Yilmaz Demirci, MD
Contact
nilgundemirci@gazi.edu.tr
009031224143
Zeki Yıldırım, professor
principal investigator · Gazi University Faculty of Medicine Chest Disease Department

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Gazi University

Start the discussion