NCT07051044

Rapid Absorbance-based Detection of Inner Cheek Cell Abnormalities Using Light Spectroscopy for Risk Evaluation of Lung Cancer to Enable Critical Decision Support in Targeted Patient Populations

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Sierra Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Overview Sierra Medical is at the forefront of early detection of lung cancer by creating AIR-DS, a non-invasive early detection test. This innovative approach aims to significantly enhance the early identification of lung cancer, potentially catching it at its most treatable stages through a simple cheek swab. How it works The effectiveness of AIR-DS stems from its ability to identify small biochemical changes in cells from the inner cheek. These biochemical changes can serve as early indicators of lung cancer. The procedure involves taking a cheek swab, which is then analysed using non-damaging infrared light technology. The RADICAL REACT study To introduce this technology into a healthcare setting the sponsor needs to validate its effectiveness through rigorous testing. The RADICAL REACT trial plans to involve around 450 participants highly suspected to have lung cancer. Each participant will provide a cheek swab and basic medical history information during a single clinic visit. The data collected will be analysed with AIR-DS to identify whether individuals with lung cancer can be identified accurately. Why it matters AIR-DS could significantly advance lung cancer detection, focusing on early, accurate diagnosis through a non-invasive cheek swab. Beyond improving patient outcomes by enabling timely intervention, it also introduces a cost-effective approach to early lung cancer detection. AIR-DS aims to alleviate the financial burden on healthcare systems and patients by reducing the need for more expensive and/or invasive diagnostic procedures.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AIR-DS	AIR-DS is a supportive, non-diagnostic, risk-indicating software that assists healthcare providers in the early detection and risk assessment of lung cancer in high-risk populations, aiming to improve the cost-effectiveness and accessibility of lung cancer screening. It is imperative to note that the efficacy of the AIR-DS may be affected by the completeness and accuracy of the input data. Hence, any missing data fields should be identified, as they could impact the risk assessment's accuracy.

Timeline

• Start date: 2025-01-02
• Primary completion: 2025-08-15
• Completion: 2026-08-15
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

2 sites across 1 country: United Kingdom