PAN-study: Pan-Cancer Early Detection Study

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    1134
  • sponsor
    Owlstone Ltd
Updated on 27 October 2022
cancer
bladder cancer
cystoscopy
bladder tumor
hematuria
Accepts healthy volunteers

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, 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.

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.

Details
Condition Gastric Cancer, Esophageal Cancer, Liver Cancer
Treatment ReCIVA, CASPER
Clinical Study IdentifierNCT03756597
SponsorOwlstone Ltd
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 30 years or over
Ability to provide informed consent

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
1. Currently in the process of investigation for a malignancy other than the
tumours of interest to this study
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
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
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
6. Asthma or COPD exacerbation requiring hospitalisation and/or
administration of oral prednisolone in past 6 weeks
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
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