Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
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

Led by Sierra Medical Ltd. · Updated on 2025-07-03

450

Participants Needed

2

Research Sites

84 weeks

Total Duration

On this page

Sponsors

S

Sierra Medical Ltd.

Lead Sponsor

Q

Queen Alexandra Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Can understand and provide signed consent
  • Are aged 18 years or older
  • Can provide a cheek swab sample
  • Are symptomatic of, and/or are being investigated for, lung cancer
  • Have not commenced treatment for lung cancer
Not Eligible

You will not qualify if you...

  • Are pregnant
  • Have been diagnosed with another known malignancy within five years (except certain localized skin, cervical, or low-grade prostate cancers)
  • Have localised oral disease such as periodontitis, bleeding gums, or dysplastic mouth disease
  • Are taking anti-coagulants
  • Have alpha 1 anti-trypsin deficiency
  • Have active infections such as tuberculosis
  • Have uncontrolled medical conditions like hypertension, asthma, chronic kidney disease, or bowel disease as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Northumbria Healthcare NHS Foundation Trust

North Shields, United Kingdom

Actively Recruiting

2

Queen Alexandra Hospital

Portsmouth, United Kingdom, PO63LY

Actively Recruiting

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Research Team

K

Kim Ibsen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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