Exhaled Breath CondensateAirBiopsyNCT07324252
Small RNA Profiling in EBC in Athletes
An observational study of Exhaled Breath Condensate and Athlete, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
Background: Exhaled breath condensate (EBC) is a non-invasively collected biofluid containing volatile and non-volatile compounds, including small RNAs. Small RNA profiling in EBC appears to be a promising approach for identifying and developing minimally invasive biomarkers for lung diseases; however, methodological… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exhaled Breath Condensate, Athlete, RNA Profile
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jan 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volouteers, amateur athletes (runners) and lung cancer patients with stage IIIb or VI disease
Who may be able to join
- ability to perform CPET
- ability to perform spirometry
Who cannot join
- lack of informed consent
- absolute contradictions to CPET or spirometry
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Respiratory Physiopathology, Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, 15-540
About this study
Official title: Feasibility of Small RNA Profiling by Next-Generation Sequencing in Exhaled Breath Condensate and Its Modulation by Maximal Exercise: a Pilot Study
Background: Exhaled breath condensate (EBC) is a non-invasively collected biofluid containing volatile and non-volatile compounds, including small RNAs. Small RNA profiling in EBC appears to be a promising approach for identifying and developing minimally invasive biomarkers for lung diseases; however, methodological evidence remains limited and heterogeneous.
Objectives: To evaluate the technical feasibility of small RNA extraction and next-generation sequencing (NGS) from EBC and to characterise small RNA profiles at rest and after maximal exercise, using EBC as a model matrix for dynamic physiological changes.
Methods: In a pilot study conducted as part of statutory research at the Medical University of Białystok (B.SUB.25.512 and B.SUB.25.529), we analysed 22 EBC samples collected with the RTube device from 11 healthy volunteers and 3 patients with lung cancer and co-existing COPD (GOLD 3-4), at rest and after standardised maximal exercise confirmed by cardiopulmonary exercise testing (CPET). Total RNA was extracted using a commercial high-throughput RNA isolation kit designed for biological samples with low nucleic acid content, the miRNeasy Serum/Plasma Advanced Kit (Qiagen), according to the manufacturer's protocol with modifications. Small RNA libraries were generated using the high-sensitivity, low-input TrueQuant Small RNA-Seq Library Preparation Kit (GenXPro GmbH) with Unique Molecular Identifiers (UMIs) and sequenced on an Illumina platform. Reads were processed with Cutadapt and FastQC, mapped iteratively to the hg38 (Homo sapiens) reference genome using Bowtie2, aligned against an array of RNA databases, including miRNA (miRBase), tRNA (GtRNAdb), piRNA (piRNAdb), ncRNA (ENSEMBL), and cDNA (ENSEMBL) and quantified with HTSeq. Differential expression analysis (DEA) and principal component analysis (PCA) were performed with DESeq2.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exhaled breath condensate donors | athletes (22) and lung cancer (3) donors of EBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
smallRNA profile
Measured: From August 2025 to December 2025
EBC collection
Measured: From January 2025 to August 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start5 Jan 2025
- Primary completion30 Aug 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exhaled Breath CondensateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukasz Minarowski, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324252
- Sponsor's protocol ID
- APK.002.584.2024
- Other IDs
- B.SUB.25.512
- Acronym
- AirBiopsy
- Status last verified
- Feb 2026
- First submitted
- 23 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: detailed RNA profile and clinical data available on demand
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Small RNA Profiling by Next-Generation Sequencing in Exhaled Breath Condensate and Its Modulation by Maximal Exercise: a Pilot Study
- ClinicalTrials.gov ID
- NCT07324252
- Acronym / sponsor ID
- AirBiopsy / APK.002.584.2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Exhaled breath condensate (EBC) is a non-invasively collected biofluid containing volatile and non-volatile compounds, including small RNAs. Small RNA profiling in EBC appears to be a promising approach for identifying and developing minimally invasive biomarkers for lung diseases; however, methodological evidence remains limited and heterogeneous.
Objectives: To evaluate the technical feasibility of small RNA extraction and next-generation sequencing (NGS) from EBC and to characterise small RNA profiles at rest and after maximal exercise, using EBC as a model matrix for dynamic physiological changes.
Methods: In a pilot study conducted as part of statutory research at the Medical University of Białystok (B.SUB.25.512 and B.SUB.25.529), we analysed 22 EBC samples collected with the RTube device from 11 healthy volunteers and 3 patients with lung cancer and co-existing COPD (GOLD 3-4), at rest and after standardised maximal exercise confirmed by cardiopulmonary exercise testing (CPET). Total RNA was extracted using a commercial high-throughput RNA isolation kit designed for biological samples with low nucleic acid content, the miRNeasy Serum/Plasma Advanced Kit (Qiagen), according to the manufacturer's protocol with modifications. Small RNA libraries were generated using the high-sensitivity, low-input TrueQuant Small RNA-Seq Library Preparation Kit (GenXPro GmbH) with Unique Molecular Identifiers (UMIs) and sequenced on an Illumina platform. Reads were processed with Cutadapt and FastQC, mapped iteratively to the hg38 (Homo sapiens) reference genome using Bowtie2, aligned against an array of RNA databases, including miRNA (miRBase), tRNA (GtRNAdb), piRNA (piRNAdb), ncRNA (ENSEMBL), and cDNA (ENSEMBL) and quantified with HTSeq. Differential expression analysis (DEA) and principal component analysis (PCA) were performed with DESeq2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exhaled breath condensate donors | – | –athletes (22) and lung cancer (3) donors of EBC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volouteers, amateur athletes (runners) and lung cancer patients with stage IIIb or VI disease
Key inclusion criteria (2 listed)
- ability to perform CPET
- ability to perform spirometry
Key exclusion criteria (2 listed)
- lack of informed consent
- absolute contradictions to CPET or spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
smallRNA profile
Time frame: From August 2025 to December 2025
EBC collection
Time frame: From January 2025 to August 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. detailed RNA profile and clinical data available on demand
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exhaled Breath Condensate and Athlete, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smallRNA profile (time frame: From August 2025 to December 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.