Integration of Liquid Biopsy into Lung Cancer Diagnostic Pathway.

Research Aims

• The introduction of a non-invasive blood test(called ctDNA) for patients with a high suspicion of lung cancer will shorten the time from referral to the start of treatment. Personalised treatment will be guided by the blood test result.

• Early treatment should mean better outcomes for patients.

Objectives

• Blood samples will be collected from patients with a high suspicion of lung cancer.

• The Genomic results from the ctDNA test will be made available to the lung cancer multidisciplinary team meeting(MDT), where cancer diagnosis and treatment decisions are made.

• Patients will receive personalised treatment after the MDT without the further delay of waiting for the genomic report from the tissue biopsy.

Background

Cancer genomic profiling is the mainstay of personalised cancer treatment and allows clinicians to select the most appropriate treatment for the individual patient. Clinical trials have proved that targeted therapies improves patient outcomes, including survival, and has fewer side effects than chemotherapy or immunotherapy. They are also convenient for patients as they can be taken orally compared to intravenous hospital based chemotherapy/immunotherapy. It is vital for doctors and patients to receive a genomic profile with their diagnosis as early as possible, as this will direct patients towards the most effective therapy. In the current diagnostic pathway, genomic analysis is requested from tissue biopsy at the lung cancer multidisciplinary(MDT) meeting, around 21-28 days after the first referral. Following the MDT, genomic analysis can take 14-24 days or longer if repeat biopsies are required. The current pathway is not acceptable or efficient for clinicians or patients.

Patients with advanced disease often deteriorate rapidly and become too unwell or die if no treatment is received and a potential treatment opportunity is lost. Liquid biopsy (a blood sample) collected early in the diagnostic pathway, before biopsy, could transform and improve timelines by providing genomic results for MDT, and allowing access to the most appropriate therapy sooner. Additionally, patients may avoid repeat 'risky' biopsy procedures.

What you hope to discover

In this study, we will compare the new ctDNA diagnostic pathway to the current tissue biopsy diagnostic pathway.

Timing:

• Can ctDNA be used to deliver genomic results to inform treatment decisions sooner than tissue biopsy-based approaches?

• Can we start appropriate, personalised treatment sooner in patients diagnosed with lung cancer in the ctDNA pathway than the standard pathway?

Patient outcomes:

• Can we improve survival in patients with lung cancer by improving access to personalised therapy at an earlier time?

Public involvement

Patients have been involved in the study's design from the outset and wil l participate in the management of the project. In addition, ctDNA testing was presented to the Genomic Partnership Wales Patient Sounding Board 2021 and was widely supported.

Dissemination

The results of this project will be sent to participants with a 'thank you' letter. The wider public will be informed via public and social media, Wales Cancer Research Centre, Welsh Cancer BioBank and Genomic Partnership Wales websites. We plan to present results at conferences and through publications in scientific journals. The results will inform the planning of future national cancer pathway and funding for future liquid biopsy services in NHS Wales.