RecruitingNCT07051044

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


Sponsor

Sierra Medical Ltd.

Enrollment

450 participants

Start Date

Jan 2, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new non-invasive technology that uses light to analyze cells collected from the inside of the cheek (a simple cheek swab) to detect abnormalities that may indicate lung cancer — potentially providing an easier and faster way to support lung cancer diagnosis. **You may be eligible if:** - You are 18 or older - You have symptoms being investigated for possible lung cancer - You have not yet started treatment for lung cancer - You are able to provide a cheek swab sample and give informed consent **You may NOT be eligible if:** - You are pregnant - You have been diagnosed with another cancer in the past 5 years (excluding certain skin or low-grade cancers) - You have a local oral condition such as gum disease, bleeding gums, or a mouth disease - You are taking blood-thinning medication - You have other significant medical conditions that could interfere with the test results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAIR-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.


Locations(2)

Northumbria Healthcare NHS Foundation Trust

North Shields, United Kingdom

Queen Alexandra Hospital

Portsmouth, United Kingdom

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NCT07051044


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