A Pilot Study of the VosCryoTM Breathalyser in Lung Cancer

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.

Sex

All

Minimum age

16 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

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

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