iquid biopsy testing in the diagnosis of lung cancer

Not Applicable

• Conditions: Patients with suspected stage III (excluding radical treatment) and IV lung cancer based on computer tomography (CT scan) and have tissue biopsy (SOC) diagnostic testing planned; Cancer

• Registration Number: ISRCTN22734699
• Lead Sponsor: Aneurin Bevan University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-19
• Last Update Posted: 18 July 2023
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1260

Inclusion Criteria

1. Be willing and able to provide written informed consent for the study
2. Age 16 years or over on day of signing informed consent
3. Have radiologically suspected advanced stage III (excluding radical treatment) and stage IV lung cancer from CT scan as evaluated and reported by clinical team and/or a radiologist
4. Consent to have a genetic analysis performed on ctDNA from their blood sample
5. Have a performance status of 0 or 3 on the ECOG Performance Scale

Exclusion Criteria

1. Is unable or unwilling to comply with study procedures
2. Stage I, II, or III suspected lung cancer that qualifies for radical treatment (surgery, radical radiotherapy or chemoradiotherapy)
3. Have any known concurrent malignancy

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured using patient records at the end of the study:<br> 1. Time from participant’s first appointment at the Rapid Access Clinic to start of treatment allocation in the two cohorts of comparison (liquid biopsy testing vs. tissue SoC tissue biopsy testing) at an early stage in the lung cancer diagnostic pathway<br> 2. Patients’ allocation to treatment in the two cohorts of test (liquid biopsy testing vs. tissue SoC tissue biopsy testing) in the lung cancer diagnostic pathway<br>

Secondary Outcome Measures

Name	Time	Method
<br> Measured using patient records at the end of the study:<br> 1. Time from sample collection to genomic report in the two cohorts of comparison (liquid biopsy vs. SoC tissue biopsy)<br> 2. Time from suspected diagnosis of lung cancer on CT scan until the first day of treatment<br> 3. Detection of actionable variants by NGS ctDNA panel compared to the SOC tissue diagnostic testing<br> 4. Failure to detect actionable variants by NGS ctDNA panel compared to the SOC tissue diagnostic testing<br> 5. Patients’ response to treatment (RT), Progression-free survival (PFS) and Overall Survival (OS) in the two cohorts of comparison<br> 6. Number of prevented repeat tissue biopsies in the ctDNA cohort compared to the SoC tissue cohort<br>