Advanced Lung CancerCryoPilotNCT07689968
A Pilot Study of the VosCryoTM Breathalyser in Lung Cancer
An observational study of Advanced Lung Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Lung Cancer
- What is being tested?
- Expiratory Breath Condensate Collection
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2026to 1 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
STH Clinical Research & Innovation Office contact
United Kingdom1 site
Weston Park Cancer Centre
Sheffield, South Yorkshire, S10 2SJ
Robin J Young, MBChB MRCP PhD, +441142265000, robin.young@nhs.net
Daniel Habershon, MSc, sth.specialisedcancerresearchadministration@nhs.net
About this study
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.
Read more
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.
Read the detailed description
Lung cancer remains one of the leading causes of cancer-related mortality worldwide, with late-stage diagnosis contributing substantially to poor prognosis (Bray et al., 2024). Despite advancements in imaging and molecular diagnostics, early detection strategies remain inadequate for population-wide screening, particularly in resource-limited settings. There is therefore an urgent need for novel, non-invasive, and cost-effective diagnostic approaches suitable for use in at-risk populations, such as individuals with a family history of lung cancer or those with a history of significant exposure to tobacco smoke.
Exhaled breath condensate (EBC) offers a promising, non-invasive source of biomarkers for respiratory diseases including lung cancer (Carpagnano et al., 2005; Palomba et al., 2023). EBC is a biological fluid formed by the cooling of exhaled breath and contains aerosolised droplets from the respiratory tract, including proteins, nucleic acids, volatile organic compounds, and, occasionally, cellular material (Horvath et al., 2005; Mutlu et al., 2001). These components may reflect pathological processes occurring in the lower airways and alveoli, thus offering a window into the disease state without the risks associated with bronchoscopy or biopsy.
Recent technological developments have enabled the reproducible collection of small volumes of EBC in a clinically practical timeframe. The VosCryo™ device, is a commercially available disposable device that collects approximately 100-200 µL of condensate in about one minute. The VosCryo™ which we will use, is a fast, non-invasive, and reliable EBC collector, optimized for small-volume sampling (50-200 µL/min).
Primarily the study aims to determine whether small-volume EBC obtained via VosCryo™ from late-stage lung cancer patients contains quantifiable and analysable cellular material, including epithelial cells, leukocytes, or exfoliated tumour cells. This will be determined from the proportion of participants with lung cancer with analysable material within their exhaled breath condensate. The study also aims to compare the presence and quality of such material with that obtained from healthy relatives (acting as a low-risk control group), to assess whether EBC-based analysis may differentiate between cancer and non-cancer states, and therefore will recruit from two cohorts - patients with late stage lung cancer and relatives of late-stage cancer patients with no evidence/low risk of cancer. This exploratory pilot study will inform the viability of future development of EBC as a low-cost, non-invasive diagnostic in patients with advanced and early-stage lung cancer, and as a potential screening tool for use in at-risk populations, and may lead to larger scale studies.
This will be a single-centre pilot study run at Weston Park Cancer Centre in Sheffield, United Kingdom, with patients and relatives recruited by clinical/medical oncologists and clinical trials assistants during their routine oncology clinic appointments. Patients attending the lung cancer clinic without an accompanying relative can be approached for study participation. Consenting patients with an accompanying relative who declines study participation can be included, as can consenting relatives with a patient who declines.
With patient consent, the study will collect a range of data at the single baseline visit for descriptive statistical analysis, including:
- Sex.
- Age.
- Smoking status - never smoker, ex-smoker (not smoked >12 months), recent ex-smoker (smoked ≤12 months), current smoker (smoked within past 14 days), vapes.
- TNM tumour stage 9th edition (where appropriate) from most recent staging scans performed as part of NHS standard of care.
- Tumour histology (where appropriate) including histological subtype, immunohistochemistry profile, mutation profile and PD-L1 status from results reported as part of NHS standard of care investigations.
- History of any concurrent pulmonary disease (e.g. emphysema, interstitial lung disease)
EBC Research Samples will be analysed using immunocytochemistry, indirect RNA extraction, cDNA synthesis and qPCR-based analysis of genes expressed in epithelial and immune cell types. The samples will also be stored for the duration of the project (18 months), and may be re-analysed in future projects using techniques such as ELISA, fluorescence microscopy or mass spectrometry.
It is estimated that participant recruitment and sample collection will be completed over a 6-month period, with subsequent sample and data analysis completing over an additional 12-month period.
- Conditions
- Advanced Lung Cancer
- Being tested
- Expiratory Breath Condensate Collection
- Keywords
- Late-Stage Lung Cancer, Lung Cancer, Advanced Lung Cancer, EBC
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Breath Condensate CollectionOther
Collection of Expiratory Breath Condensate using the VosCryo device
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Patients with advanced/late-stage lung cancer Receives: Other: Expiratory Breath Condensate Collection | |
| Control Arm | Relatives of advanced lung cancer patients, at low risk of/with no known malignancy. Receives: Other: Expiratory Breath Condensate Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Collection of EBC Sample
Secondary 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.
Measured: Variation in gene expression identified at end of study, from samples collected at baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Advanced Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Robin J Young, MBChB MRCP PhD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689968
- Sponsor's protocol ID
- STH23461
- Other IDs
- IRAS
- Acronym
- CryoPilot
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For protection of participants, raw individual participant data will not be distributed outside of the immediate research team. Pseudonymised individual data will be transferred to partnering organisations (e.g., University of Sheffield) for data analysis purposes, and overall findings will be relayed to participants and may be publicised in academic journals/conferences, however IPD will be retained by the immediate study team.
Publications
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.
PubMed 12796197Palomba 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.
PubMed 37387613Mutlu 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.
PubMed 11549524Kharitonov SA, Barnes PJ. Exhaled biomarkers. Chest. 2006 Nov;130(5):1541-6. doi: 10.1378/chest.130.5.1541.
PubMed 17099035Horvath 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.
PubMed 16135737Department 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/)
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.
PubMed 15947287Bray 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.
PubMed 38572751
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the VosCryoTM Breathalyser in Lung Cancer
- ClinicalTrials.gov ID
- NCT07689968
- Acronym / sponsor ID
- CryoPilot / STH23461
- Conditions
- Advanced Lung Cancer
- Keywords
- Late-Stage Lung Cancer, Lung Cancer, Advanced Lung Cancer, EBC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lung cancer remains one of the leading causes of cancer-related mortality worldwide, with late-stage diagnosis contributing substantially to poor prognosis (Bray et al., 2024). Despite advancements in imaging and molecular diagnostics, early detection strategies remain inadequate for population-wide screening, particularly in resource-limited settings. There is therefore an urgent need for novel, non-invasive, and cost-effective diagnostic approaches suitable for use in at-risk populations, such as individuals with a family history of lung cancer or those with a history of significant exposure to tobacco smoke.
Exhaled breath condensate (EBC) offers a promising, non-invasive source of biomarkers for respiratory diseases including lung cancer (Carpagnano et al., 2005; Palomba et al., 2023). EBC is a biological fluid formed by the cooling of exhaled breath and contains aerosolised droplets from the respiratory tract, including proteins, nucleic acids, volatile organic compounds, and, occasionally, cellular material (Horvath et al., 2005; Mutlu et al., 2001). These components may reflect pathological processes occurring in the lower airways and alveoli, thus offering a window into the disease state without the risks associated with bronchoscopy or biopsy.
Recent technological developments have enabled the reproducible collection of small volumes of EBC in a clinically practical timeframe. The VosCryo™ device, is a commercially available disposable device that collects approximately 100-200 µL of condensate in about one minute. The VosCryo™ which we will use, is a fast, non-invasive, and reliable EBC collector, optimized for small-volume sampling (50-200 µL/min).
Primarily the study aims to determine whether small-volume EBC obtained via VosCryo™ from late-stage lung cancer patients contains quantifiable and analysable cellular material, including epithelial cells, leukocytes, or exfoliated tumour cells. This will be determined from the proportion of participants with lung cancer with analysable material within their exhaled breath condensate. The study also aims to compare the presence and quality of such material with that obtained from healthy relatives (acting as a low-risk control group), to assess whether EBC-based analysis may differentiate between cancer and non-cancer states, and therefore will recruit from two cohorts - patients with late stage lung cancer and relatives of late-stage cancer patients with no evidence/low risk of cancer. This exploratory pilot study will inform the viability of future development of EBC as a low-cost, non-invasive diagnostic in patients with advanced and early-stage lung cancer, and as a potential screening tool for use in at-risk populations, and may lead to larger scale studies.
This will be a single-centre pilot study run at Weston Park Cancer Centre in Sheffield, United Kingdom, with patients and relatives recruited by clinical/medical oncologists and clinical trials assistants during their routine oncology clinic appointments. Patients attending the lung cancer clinic without an accompanying relative can be approached for study participation. Consenting patients with an accompanying relative who declines study participation can be included, as can consenting relatives with a patient who declines.
With patient consent, the study will collect a range of data at the single baseline visit for descriptive statistical analysis, including:
- Sex.
- Age.
- Smoking status - never smoker, ex-smoker (not smoked >12 months), recent ex-smoker (smoked ≤12 months), current smoker (smoked within past 14 days), vapes.
- TNM tumour stage 9th edition (where appropriate) from most recent staging scans performed as part of NHS standard of care.
- Tumour histology (where appropriate) including histological subtype, immunohistochemistry profile, mutation profile and PD-L1 status from results reported as part of NHS standard of care investigations.
- History of any concurrent pulmonary disease (e.g. emphysema, interstitial lung disease)
EBC Research Samples will be analysed using immunocytochemistry, indirect RNA extraction, cDNA synthesis and qPCR-based analysis of genes expressed in epithelial and immune cell types. The samples will also be stored for the duration of the project (18 months), and may be re-analysed in future projects using techniques such as ELISA, fluorescence microscopy or mass spectrometry.
It is estimated that participant recruitment and sample collection will be completed over a 6-month period, with subsequent sample and data analysis completing over an additional 12-month period.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | – | Other: Expiratory Breath Condensate CollectionPatients with advanced/late-stage lung cancer |
| Control Arm | – | Other: Expiratory Breath Condensate CollectionRelatives of advanced lung cancer patients, at low risk of/with no known malignancy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- Participants with lung metastases from non-lung primary tumours
- Participants unable to consent or unable to comply with the requirements for EBC sample collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expiratory Breath Condensate CollectionCollection of Expiratory Breath Condensate using the VosCryo device | Other | Control Arm, Experimental Arm |
Primary outcome
Availability of Analysable Sample Material
Time frame: At Collection of EBC Sample
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.
1 secondary outcome
Cross-Cohort Sample Discrepancy
Time frame: Variation in gene expression identified at end of study, from samples collected at baseline visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 12796197Phillips 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.
- Background: PubMed 37387613Palomba 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.
- Background: PubMed 11549524Mutlu 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.
- Background: PubMed 17099035Kharitonov SA, Barnes PJ. Exhaled biomarkers. Chest. 2006 Nov;130(5):1541-6. doi: 10.1378/chest.130.5.1541.
- Background: PubMed 16135737Horvath 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.
- BackgroundDepartment 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: PubMed 15947287Carpagnano 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.
- Background: PubMed 38572751Bray 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.
- Individual participant dataSharing planned: No. For protection of participants, raw individual participant data will not be distributed outside of the immediate research team. Pseudonymised individual data will be transferred to partnering organisations (e.g., University of Sheffield) for data analysis purposes, and overall findings will be relayed to participants and may be publicised in academic journals/conferences, however IPD will be retained by the immediate study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
STH Clinical Research & Innovation Office contact
Robin J Young, MBChB MRCP PhD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Lung Cancer, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin J Young, MBChB MRCP PhD (+441142265000, robin.young@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Availability of Analysable Sample Material (time frame: At Collection of EBC Sample). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07689968, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.