A Pilot Study of the VosCryoTM Breathalyser in Lung Cancer

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorSheffield Teaching Hospitals NHS Foundation Trust

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

24 Participants
are divided into 2 treatment groups

Sponsors and collaborators