About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Participants with lung metastases from non-lung primary tumours
Participants unable to consent or unable to comply with the requirements for EBC sample collection
Trial design
Treatments tested in this trial
- Expiratory Breath Condensate Collection
Treatment groups
Sponsors and collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Lead sponsor
University of Sheffield
Collaborator