None listed
Conditions
Brief summary
The purpose of this study is to determine the practicality of a new blood test called droplet digital PCR (ddPCR) to detect circulating tumour DNA in early stage lung cancer patients. Who is it for? You may be eligible for this study if you are an adult who has suspected or proven non-small cell lung cancer. Study details Participants will provide blood samples and a sample of lung tumour at time of surgery. Participants will be reviewed one month post-surgery and then every 6 months for 3 years, with a clinical review, CT scan and blood test completed at each follow up. Participants will be reviewed at 4 and 5 years with a clinical review and CT scan. It is hoped this research will enable doctors in the future to use this new blood test to better predict outcomes of cancer surgery in order to determine the best post-operative treatment required for each individual participant.
Interventions
This study will evaluate the practicality of droplet digital PCR (ddPCR) assays based on chromosome rearrangements to detect circulating tumour DNA (ctDNA) especially for longitudinal assessment of disease in a cohort of lung cancer patients with early stage tumours that initially undergo surgically resection. The hypothesis is that ctDNA can be detected at an unprecedented level of sensitivity and accuracy by using (ddPCR) assays that use patient tumour-specific rearrangements as highly specifi
This study will evaluate the practicality of droplet digital PCR (ddPCR) assays based on chromosome rearrangements to detect circulating tumour DNA (ctDNA) especially for longitudinal assessment of disease in a cohort of lung cancer patients with early stage tumours that initially undergo surgically resection. The hypothesis is that ctDNA can be detected at an unprecedented level of sensitivity and accuracy by using (ddPCR) assays that use patient tumour-specific rearrangements as highly specific (individualised) tumour biomarkers. Participants will give consent to provide a tumour sample at time of surgery. 40ml blood samples at day of surgery, day 4, day 30 and then 6 monthly for 36 months. Clinical review including physical exam at 1 month. Clinic review including physical exam and CT Chest scan at 6 months and then 6 monthly for 36 months. Clinic review including physical exam and CT Chest scan at years 4 and 5.
Sponsors
Associate Professor Alexander Dobrovic
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
Inclusion criteria: 1. Patient with suspected or proven stage I – IIIA NSCLC requiring surgical resection. 2. Availability of tumour tissue for the purpose of DNA analysis, (either prior to or during surgery) with enough tumour material of at least 50% tumour purity to yield sufficient DNA (1-2ug) for whole genome sequencing 3. Age greater than or equal to 18
Exclusion criteria
Exclusion criteria: 1. Persons with a cognitive impairment, intellectual disability or mental illness who are not competent to consent. 2. Patients unfit for lung cancer resection.
Outcome results
None listed