A Pilot Study of the VosCryoTM Breathalyser in Lung Cancer
ConditionAdvanced 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
This trial accepts healthy volunteersQualifiers
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 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
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Expiratory Breath Condensate Collection
Other interventionCollection of Expiratory Breath Condensate using the VosCryo device
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Experimental Arm1 intervention
Group B: Control Arm1 intervention
Trial outcomes
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.
Time frame
At Collection of EBC SampleSecondary outcomes
1
Cross-Cohort Sample Discrepancy
Variation in gene expression in epithelial and immune cells between advanced lung cancer patients and healthy controls, as demonstrated by RNA extraction, cDNA synthesis and qPCR-based analysis of EBC samples.
Time frame
Variation in gene expression identified at end of study, from samples collected at baseline visit.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sheffield Teaching Hospitals NHS Foundation Trust
Lead sponsor
University of Sheffield
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: