None listed
Conditions
Brief summary
Lung cancer is the leading cause of cancer related death and disproportionately disadvantages Maori both in incidence and mortality rates. In New Zealand, pathological diagnosis and staging can take months and is absent for one out of five patients with lung cancer. Our study aims to develop a blood-based diagnostic test using circulating tumour DNA (ctDNA) to rapidly identify oncogenic mutations so that patients can be started on appropriate, effective treatment sooner. This study will recruit fifty patients with suspected metastatic lung cancer who are unable to obtain a biopsy. Eligible patients will undergo blood-based testing and surveys about the acceptability of the test.
Interventions
40ml of blood will be collected once only by a study nurse for diagnostic test (circulating tumour DNA) from consented eligible patients, as part of their diagnostic work up. Three assays will be used, the comprehensive ctDNA test is a FDA approved test in clinical practice (though not reimbursed in Australia and NZ), The other two assays (lung focussed NGS panel and droplet digital PCR are research use only, although they will be carried out in a clinical laboratory).
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant is willing and able to give informed consent for participation in the trial. 2. Male or female, aged 18 years or above. 3. Radiological advanced lung cancer (distant metastases as per American Joint Committee on Cancer (AJCC) 8th edition Tumour, Nodes, Metastasis (TNM) staging, stage M1a, M1b or M1c) 4. Radiologist confirmed suspicion of malignancy on chest X-Ray (CXR) or computerised tomography (CT) and clinician opinion likely lung cancer primary 5. Not suitable for cytotoxic chemotherapy but fit for molecularly targeted treatment, due to patient comorbidity, performance status or patient preference 6. Unable to pursue molecular testing of a histological sample a. Due to anatomical location/risk of complications or, b. Due to patient preference or, c. Due to insufficient material for molecular testing 7. Life expectancy expected more than 4 weeks 8. In the Investigator’s opinion, is able and willing to comply with all trial requirements. 9. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Exclusion criteria
• European Cooperative Oncology Group Performance status (ECOG PS) 4 • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
Outcome results
None listed