A Pilot Study of the VosCryoTM Breathalyser in Lung Cancer

NCT07689968 | Not Yet Recruiting

• 2 other identifiers: STH23461IRAS
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

CryoPilot is a single-centre pilot study being conducted at Weston Park Cancer Centre in Sheffield, UK. The goal of this pilot study is to determine whether small-volume exhaled breath condensate sample (EBC) obtained via a VosCryo™ breath sample collection device can provide quantifiable and analysable cellular material, including epithelial cells, leukocytes, or exfoliated tumour cells, in patients with late-stage lung cancer. The main question it aims to answer is whether a breath sample can provide the necessary cellular information that could eventually be used for diagnostic purposes. The secondary objective is to compare the presence and quality of such material with that obtained from healthy relatives who will act as a low-risk control group, to assess whether EBC-based analysis may differentiate between cancerous and non-cancerous states. As such this pilot study will have two arms:

• Experimental arm: 12 patients with late-stage lung cancer
• Control arm: 12 low-risk relatives of patients with late-stage lung cancer Participants will be approached during their visit to Weston Park Hospital and asked to provide informed consent, followed by provision of a breath sample.

Conditions

Advanced Lung Cancer

Keywords

Late-Stage Lung Cancer; Lung Cancer; Advanced Lung Cancer; EBC

Outcome Measures

Primary Outcomes (1)

• Availability of Analysable Sample Material

  The number of participants with lung cancer out of the total recruited to the experimental arm, who have analysable material within their exhaled breath condensate.

  At Collection of EBC Sample

Secondary Outcomes (1)

• Cross-Cohort Sample Discrepancy

  Variation in gene expression identified at end of study, from samples collected at baseline visit.

Study Arms (2)

Experimental Arm

Patients with advanced/late-stage lung cancer

Other: Expiratory Breath Condensate Collection

Control Arm

Relatives of advanced lung cancer patients, at low risk of/with no known malignancy.

Other: Expiratory Breath Condensate Collection

Interventions

Expiratory Breath Condensate Collection OTHER

Collection of Expiratory Breath Condensate using the VosCryo device

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of two cohorts of participants: * Patients with previously untreated advanced lung cancer, who meet the relevant inclusion criteria and are under treatment at or have been referred to Weston Park Hospital * Friends or relatives with no history of lung cancer, who are accompanying a patient with advanced lung cancer to Weston Park Hospital

You may qualify if:

• Age ≥16 years old
• Ability to provide written informed consent
• Either a history of advanced non-small cell or small cell lung cancer with intra-thoracic disease (pulmonary primary or pulmonary metastases), previously untreated by systemic anti-cancer treatment or radiotherapy
• Patients with previously treated early-stage lung cancer are permitted
• Patients with advanced disease with extra-thoracic disease previously treated by local therapy (e.g., palliative radiotherapy to a bone metastasis, or post brain metastectomy), which in the opinion of the Principal Investigator is unlikely to impact the quality of the EBC research sample are eligible
• OR an attending relative or friend with no history of lung cancer or any other primary cancer, except for curatively treated non-melanomatous skin cancer or carcinoma in situ, unless the participant has been free of malignancy and off treatment for a period of at least 2 years prior to study enrolment
• No intercurrent upper or lower respiratory tract infection
• Able to complete the EBC sample collection

You may not qualify if:

• Participants with lung metastases from non-lung primary tumours
• Participants unable to consent or unable to comply with the requirements for EBC sample collection

Sponsors & Collaborators

• University of Sheffield: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Weston Park Cancer Centre

Sheffield, South Yorkshire, S10 2SJ, United Kingdom

Location

Related Publications (8)

• Phillips M, Cataneo RN, Cummin AR, Gagliardi AJ, Gleeson K, Greenberg J, Maxfield RA, Rom WN. Detection of lung cancer with volatile markers in the breath. Chest. 2003 Jun;123(6):2115-23. doi: 10.1378/chest.123.6.2115.

  PMID: 12796197 BACKGROUND

• Palomba L, Paris D, Tramice A, Ambrosino P, Maniscalco M, Motta A. Detection of Cells in Exhaled Breath Condensate Holds Potential for Pathophysiological Insights in Pulmonary Diseases. Am J Respir Cell Mol Biol. 2023 Jul;69(1):113-115. doi: 10.1165/rcmb.2023-0022LE. No abstract available.

  PMID: 37387613 BACKGROUND

• Mutlu GM, Garey KW, Robbins RA, Danziger LH, Rubinstein I. Collection and analysis of exhaled breath condensate in humans. Am J Respir Crit Care Med. 2001 Sep 1;164(5):731-7. doi: 10.1164/ajrccm.164.5.2101032. No abstract available.

  PMID: 11549524 BACKGROUND

• Kharitonov SA, Barnes PJ. Exhaled biomarkers. Chest. 2006 Nov;130(5):1541-6. doi: 10.1378/chest.130.5.1541.

  PMID: 17099035 BACKGROUND

• 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

• Department of Health and Social Care. (2017). UK Policy Framework for Health and Social Care Research. (accessed at https://www.hra.nhs.uk/planning-and-improving-research/policies-standards- legislation/uk-policy-framework-health-social-care-research/)

  BACKGROUND

• Carpagnano GE, Foschino-Barbaro MP, Mule G, Resta O, Tommasi S, Mangia A, Carpagnano F, Stea G, Susca A, Di Gioia G, De Lena M, Paradiso A. 3p microsatellite alterations in exhaled breath condensate from patients with non-small cell lung cancer. Am J Respir Crit Care Med. 2005 Sep 15;172(6):738-44. doi: 10.1164/rccm.200503-439OC. Epub 2005 Jun 9.

  PMID: 15947287 BACKGROUND

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

EBC samples will be stored at -20c for the duration of the project. Samples may be used for future and/or subsequent follow-on trials.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robin J Young, MBChB MRCP PhD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin J Young, MBChB MRCP PhD

CONTACT

+441142265000; robin.young@nhs.net

STH Clinical Research & Innovation Office

CONTACT

sth.researchadministration@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)