Gastric CancerNCT03756597
PAN-study: Pan-Cancer Early Detection Study (PAN)
An observational study of Gastric Cancer and Esophageal Cancer, run by Owlstone Ltd at 1 site in United Kingdom.
Trial summary
The PAN-cancer Early Detection study or PAN-study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy can differentiate between patients with and without different cancer types by comparing breath biomarkers for a range of cancer types including patients with gastric… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Esophageal Cancer, Liver Cancer
- What is being tested?
- ReCIVA and CASPER
- Type of treatment
- Medical device
- How many people
- 268 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2018to 6 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The inclusion and exclusion criteria for the various study populations are detailed above. General inclusion and exclusion criteria which apply to all study subjects are detailed followed by indication specific criteria are also detailed for both inclusion and exclusion.
5.1. General inclusion criteria
- Aged 30 years or over
- Ability to provide informed consent
5.2. General exclusion criteria
- (Anticipated) inability to complete the breath sampling procedure due to e.g. inability to maintain adequate ventilation unaided or claustrophobia
- Participation in a Clinical Trial Investigational Medicinal Product (CTIMP) during the 28 days prior to breath biopsy.
- Any biopsy or endoscopic procedure conducted during the past 48 hours. A breath sample can be collected >48 hours post procedure.
- Any disorder that is not stable in the opinion of the investigator. Specifically, subjects should be excluded if: 4.1. Currently in the process of investigation for a malignancy other than the tumours of interest to this study. 4.2. A history of malignancy, unless treated with curative intent and cancer-free at least 2 years prior to inclusion. Patients previously treated for highly localised disease e.g. basal cell carcinoma, localised squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that curative therapy was completed at least 12 months prior to inclusion. 4.3. A history of the malignancy the patient is currently being investigated for. E.g. a patient suspected of gastric cancer with previous gastric cancer in medical history 4.4. Known active bacterial, fungal or viral infection including but not limited to upper respiratory tract infection, tuberculosis, pneumonia, cystitis, pyelonephritis, gastritis, prostatitis or viral hepatitis. Patients can be recruited after being symptom free for at least 2 weeks for mild infections and 6 weeks if admitted to the hospital and/or treated with i.v. antibiotics. 4.5. Documented history of a clinically important lung condition other than asthma or COPD e.g., active lung infection, , bronchiectasis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis/mycosis, pulmonary fibrosis or hypersensitivity pneumonitis, α1- antitrypsin deficiency. If α1- antitrypsin deficiency is diagnosed after a breath sample has been taken, the patient sample may still be used for analysis. α1- antitrypsin carriers are eligible for the study. 4.6. Asthma or COPD exacerbation requiring hospitalisation and/or administration of oral prednisolone in past 6 weeks. 4.7. Renal failure stages 3b and above (eGFR 45ml/min or less) 4.8. Any hospitalisation for symptoms unrelated to the clinical presentation of the tumour under investigation during the past 6 weeks.
- Immunocompromised patients: specifically, patients with Acquired Immune Deficiency Syndrome (AIDS) (HIV with normal blood counts is eligible), inborn or acquired severe immune-deficiency including those caused by pharmacological treatment.
- Documented history of pulmonary surgery or endobronchial interventional procedures other than biopsy, lavage or bronchial brushings. These include surgical resection, VATS, bronchial thermoplasty and coiling.
- Applicable for the limonene sub-study only (see section 4.1): Non-abstinent participants with alcohol related liver disease or participants who drink to excess daily.
- Applicable for the limonene sub-study only (see section 4.1): Current smokers (or e-cigarette users) or participants who have smoked (or used e-cigarettes) in the past 6 months prior to baseline sample.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospital NHS
Cambridge, CB2 0QQ
About this study
Official title: PAN-study: Pan-Cancer Early Detection Study
The PAN-cancer Early Detection study or PAN-study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy can differentiate between patients with and without different cancer types by comparing breath biomarkers for a range of cancer types including patients with gastric, oesophageal, and liver cancer.
The research may be extended to include also pancreatic, renal, prostate and bladder cancer patients, however in agreement between Cambridge University Hospital NHS Foundation Trust, University of Cambridge, CRUK and Owlstone Medical recruitment in these arms will not start until further notice. When recruitment is planned to start in these arms, Owlstone Medical will ensure to notify the REC. Subjects with a histologically confirmed cancer will be recruited from CUH by local research staff. Breath samples will be collected by means of the ReCIVA breath sampler which requires tidal breathing into a face mask for around 10 minutes. A cancer free control subject matched for age, sex and tumour specific risk factors will be recruited and sampled.
Read the detailed description
There is a pressing need for techniques that allow detection of cancer at an earlier stage when curative treatment is more likely. Exhaled biomarkers are known to reflect a wide range of metabolic processes, including those related to cancer such as the Warburg effect. Owlstone Medical Ltd (hereafter referred to as Owlstone Medical) has developed Breath Biopsy; a workflow to collect and analyse breath Volatile Organic Compounds (VOCs) in a highly standardised way. The PAN-study is a collaborative effort between Cambridge University Hospitals NHS Foundation Trust (CUH), University of Cambridge (UoC), Cancer Research United Kingdom (CRUK) and Owlstone Medical to evaluate the potential of Breath Biopsy to detect various types of cancer by profiling breath metabolites.
The PAN-cancer Early Detection study or PAN-study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy can differentiate between patients with and without different cancer types by comparing breath biomarkers for a range of cancer types including patients with gastric, oesophageal, and liver cancer.
The research may be extended to include also pancreatic, renal, prostate and bladder cancer patients, however in agreement between Cambridge University Hospital NHS Foundation Trust, University of Cambridge, CRUK and Owlstone Medical recruitment in these arms will not start until further notice. When recruitment is planned to start in these arms, Owlstone Medical will ensure to notify the REC. Subjects with a histologically confirmed cancer will be recruited from CUH by local research staff. Breath samples will be collected by means of the ReCIVA breath sampler which requires tidal breathing into a face mask for around 10 minutes. A cancer free control subject matched for age, sex and tumour specific risk factors will be recruited and sampled. Breath samples will be shipped to Owlstone Medical for analysis of breath biomarkers by Gas Chromatography-Time Of Flight-Mass Spectrometry (GC-TOF-MS) and Gas Chromatography-Field Asymmetric Ion Mobility Spectrometry (GC-FAIMS).
This study will be the first step towards evaluating VOCs analysis as a test to improve early detection rates for cancer with future applicability to primary care. Ultimately, such a research program could enable low cost and widespread targeted screening programs for cancer.
In a subset of up to 12 patients with cirrhosis and 12 healthy volunteers, a sub study will be conducted to measure the washout of limonene after ingestion of a standardised quantity of limonene under controlled circumstance for food and drink intake.
The objective of this limonene sub-study is to demonstrate that limonene is a biomarker that differentiates between healthy individuals and cirrhotic patients with Child-Pugh grade A and B with or without HCC as a comorbidity.
Participants will be asked to visit the clinical site to provide 6 breath samples at different timepoints before and after ingestion of limonene. Participants will be asked to fast overnight for 10 hours, not to have brushed their teeth for 2 hours prior to first breath sample and not be a current smoker or should not have smoked in the past 6 months. Non-abstinent patients with alcohol related liver disease or participants who drink to excess daily will be excluded from this sub-study.
- Conditions
- Gastric Cancer, Esophageal Cancer, Liver Cancer
- Being tested
- ReCIVA, CASPER
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCIVADevice
The ReCIVA breath sampler contains a CO2 and pressure sensor, which allows the operator to monitor the breath sampling procedure and patient comfort. Both the operator and the patient can pause or abort the breath sampling procedure within seconds by removing the mask. The time investment required from patients is approximately 15 minutes for consenting and medical history and 10 minutes per breath collection.
CASPERDevice
Minimizes contamination of breath samples by external VOCs Removes need for clean air supply line
| Study group | Role | What they receive |
|---|---|---|
| Cases Pathway A | Case pathway A - Intention to diagnose population
Only patients with a very high clinical suspicion based on imaging are scheduled for surgical procedures.Subjects with a confirmed diagnosis of cancer after clinical work-up will be labelled cases. of the study.
Patients with Gastric or Oesophageal cancer will be recruited after confirmation of their diagnosis but prior to initiation of therapy. Receives: Device: ReCIVA; Device: CASPER | |
| Clinical Controls | Clinical controls represent subjects that:
* Are suspected of the same cancer or part of an at risk-group
* Have undergone full per-guideline diagnostic work-up, resulting in confirmation the subject does not have cancer (see section 6)
* Is matched to the case for age, gender and known risk-factors specific to that tumour type (section 5.4) Receives: Device: ReCIVA; Device: CASPER | |
| Healthy volunteers | Healthy volunteers will be recruited from the clinical research facility at Addenbrooke's Hospital (Cambridge) or from the Cambridge BioResource. These subjects will be selected to have a similar age and sex distribution as the overall PAN-study cases. Receives: Device: ReCIVA; Device: CASPER | |
| Substudy Cases | Patients with a confirmed diagnosis of cirrhosis and providing up to 6 samples will be labelled as the washout substudy cases Receives: Device: ReCIVA; Device: CASPER | |
| Cases Pathway B | Case pathway B - Confirmed malignancy population
Patients with a Gastric, Liver or Oesophageal cancer will be recruited after confirmation of their diagnosis but prior to initiation of therapy. Patients will be recruited by research staff at the clinic they are referred to for diagnosis and/or treatment Receives: Device: ReCIVA; Device: CASPER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints; accuracy of breath biopsy to discriminate between individuals with and without cancer
- These will include gastric, oesophageal and liver and matched controls. This analysis will be conducted by combining cases and matched controls across all cancer types as well as when stratified per tumour type. If supported by literature on the presence of potential biomarkers related to pancreatic, renal, prostate, and bladder tumours similar analysis will be done in samples collected in patients diagnosed with these cancer types and controls.
Measured: 3 years
Secondary outcomes (1)
Patient feedback on usability and acceptability of Breath Biopsy as assessed using a a structured interview
- Patient feedback on usability and acceptability, including willingness to participate.
- Qualitative review of barriers to adoption for study subjects and health professionals.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start26 Sep 2018
- Primary completion2 Dec 2022
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Prospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Owlstone Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Cancer Research UK
- Responsible party
- Sponsor
- Investigators
- Marc P van der Schee, MD, PhD, Study director, +01223 428200Prof Rebecca Fitzgerald, MD, PhD, Study chair, Cambridge University HospitalMassimiliano di Pietro, MD, PhD, Principal investigator, Cambridge University HospitalMr Vincent J Gnanapragasam, MD, PhD, Principal investigator, Cambridge University HospitalMr Grant Stewart, MD, PhD, Principal investigator, Cambridge University HospitalDr Godfrey Edmund, MD, PhD, Principal investigator, Cambridge University HospitalMiss Alexandra Colquhoun,, Principal investigator, Cambridge University HospitalDr Victoria Snowdon, Principal investigator, Cambridge University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756597
- Sponsor's protocol ID
- PAN
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2018
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAN-study: Pan-Cancer Early Detection Study
- ClinicalTrials.gov ID
- NCT03756597
- Acronym / sponsor ID
- PAN
- Conditions
- Gastric Cancer, Esophageal Cancer, Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Owlstone LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Cancer Research UK
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 28 Nov 2018 (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.
The PAN-cancer Early Detection study or PAN-study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy can differentiate between patients with and without different cancer types by comparing breath biomarkers for a range of cancer types including patients with gastric, oesophageal, and liver cancer.
The research may be extended to include also pancreatic, renal, prostate and bladder cancer patients, however in agreement between Cambridge University Hospital NHS Foundation Trust, University of Cambridge, CRUK and Owlstone Medical recruitment in these arms will not start until further notice. When recruitment is planned to start in these arms, Owlstone Medical will ensure to notify the REC. Subjects with a histologically confirmed cancer will be recruited from CUH by local research staff. Breath samples will be collected by means of the ReCIVA breath sampler which requires tidal breathing into a face mask for around 10 minutes. A cancer free control subject matched for age, sex and tumour specific risk factors will be recruited and sampled.
Detailed description
There is a pressing need for techniques that allow detection of cancer at an earlier stage when curative treatment is more likely. Exhaled biomarkers are known to reflect a wide range of metabolic processes, including those related to cancer such as the Warburg effect. Owlstone Medical Ltd (hereafter referred to as Owlstone Medical) has developed Breath Biopsy; a workflow to collect and analyse breath Volatile Organic Compounds (VOCs) in a highly standardised way. The PAN-study is a collaborative effort between Cambridge University Hospitals NHS Foundation Trust (CUH), University of Cambridge (UoC), Cancer Research United Kingdom (CRUK) and Owlstone Medical to evaluate the potential of Breath Biopsy to detect various types of cancer by profiling breath metabolites.
The PAN-cancer Early Detection study or PAN-study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy can differentiate between patients with and without different cancer types by comparing breath biomarkers for a range of cancer types including patients with gastric, oesophageal, and liver cancer.
The research may be extended to include also pancreatic, renal, prostate and bladder cancer patients, however in agreement between Cambridge University Hospital NHS Foundation Trust, University of Cambridge, CRUK and Owlstone Medical recruitment in these arms will not start until further notice. When recruitment is planned to start in these arms, Owlstone Medical will ensure to notify the REC. Subjects with a histologically confirmed cancer will be recruited from CUH by local research staff. Breath samples will be collected by means of the ReCIVA breath sampler which requires tidal breathing into a face mask for around 10 minutes. A cancer free control subject matched for age, sex and tumour specific risk factors will be recruited and sampled. Breath samples will be shipped to Owlstone Medical for analysis of breath biomarkers by Gas Chromatography-Time Of Flight-Mass Spectrometry (GC-TOF-MS) and Gas Chromatography-Field Asymmetric Ion Mobility Spectrometry (GC-FAIMS).
This study will be the first step towards evaluating VOCs analysis as a test to improve early detection rates for cancer with future applicability to primary care. Ultimately, such a research program could enable low cost and widespread targeted screening programs for cancer.
In a subset of up to 12 patients with cirrhosis and 12 healthy volunteers, a sub study will be conducted to measure the washout of limonene after ingestion of a standardised quantity of limonene under controlled circumstance for food and drink intake.
The objective of this limonene sub-study is to demonstrate that limonene is a biomarker that differentiates between healthy individuals and cirrhotic patients with Child-Pugh grade A and B with or without HCC as a comorbidity.
Participants will be asked to visit the clinical site to provide 6 breath samples at different timepoints before and after ingestion of limonene. Participants will be asked to fast overnight for 10 hours, not to have brushed their teeth for 2 hours prior to first breath sample and not be a current smoker or should not have smoked in the past 6 months. Non-abstinent patients with alcohol related liver disease or participants who drink to excess daily will be excluded from this sub-study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cases Pathway A | – | Device: ReCIVA, Device: CASPERCase pathway A - Intention to diagnose population Only patients with a very high clinical suspicion based on imaging are scheduled for surgical procedures.Subjects with a confirmed diagnosis of cancer after clinical work-up will be labelled cases. of the study. Patients with Gastric or Oesophageal cancer will be recruited after confirmation of their diagnosis but prior to initiation of therapy. |
| Clinical Controls | – | Device: ReCIVA, Device: CASPERClinical controls represent subjects that: * Are suspected of the same cancer or part of an at risk-group * Have undergone full per-guideline diagnostic work-up, resulting in confirmation the subject does not have cancer (see section 6) * Is matched to the case for age, gender and known risk-factors specific to that tumour type (section 5.4) |
| Healthy volunteers | – | Device: ReCIVA, Device: CASPERHealthy volunteers will be recruited from the clinical research facility at Addenbrooke's Hospital (Cambridge) or from the Cambridge BioResource. These subjects will be selected to have a similar age and sex distribution as the overall PAN-study cases. |
| Substudy Cases | – | Device: ReCIVA, Device: CASPERPatients with a confirmed diagnosis of cirrhosis and providing up to 6 samples will be labelled as the washout substudy cases |
| Cases Pathway B | – | Device: ReCIVA, Device: CASPERCase pathway B - Confirmed malignancy population Patients with a Gastric, Liver or Oesophageal cancer will be recruited after confirmation of their diagnosis but prior to initiation of therapy. Patients will be recruited by research staff at the clinic they are referred to for diagnosis and/or treatment |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion and exclusion criteria for the various study populations are detailed above. General inclusion and exclusion criteria which apply to all study subjects are detailed followed by indication specific criteria are also detailed for both inclusion and exclusion.
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 |
|---|---|---|
| ReCIVAThe ReCIVA breath sampler contains a CO2 and pressure sensor, which allows the operator to monitor the breath sampling procedure and patient comfort. Both the operator and the patient can pause or abort the breath sampling procedure within seconds by removing the mask. The time investment required from patients is approximately 15 minutes for consenting and medical history and 10 minutes per breath collection. | Device | Cases Pathway A, Cases Pathway B, Clinical Controls, Healthy volunteers, Substudy Cases |
| CASPERMinimizes contamination of breath samples by external VOCs Removes need for clean air supply line | Device | Cases Pathway A, Cases Pathway B, Clinical Controls, Healthy volunteers, Substudy Cases |
Primary outcome
Primary endpoints; accuracy of breath biopsy to discriminate between individuals with and without cancer
Time frame: 3 years
o These will include gastric, oesophageal and liver and matched controls. This analysis will be conducted by combining cases and matched controls across all cancer types as well as when stratified per tumour type. If supported by literature on the presence of potential biomarkers related to pancreatic, renal, prostate, and bladder tumours similar analysis will be done in samples collected in patients diagnosed with these cancer types and controls.
1 secondary outcome
Patient feedback on usability and acceptability of Breath Biopsy as assessed using a a structured interview
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- PAN study websiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Marc P van der Schee, MD, PhD study director
+01223 428200
Prof Rebecca Fitzgerald, MD, PhD study chair
Cambridge University Hospital
Massimiliano di Pietro, MD, PhD principal investigator
Cambridge University Hospital
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 Gastric Cancer and Esophageal Cancer, run by Owlstone Ltd 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?
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: finished, as of the sponsor's last update on 5 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints; accuracy of breath biopsy to discriminate between individuals with and without cancer (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2023.