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NCT Number: 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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible to participate in this study, study participants must meet all the following criteria:

  • 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.

Exclusion criteria

Study participants who meet any of the following criteria will be excluded from participation in this study:

  • Are pregnant.
  • Have been diagnosed with another known malignancy within five years (excluding localised squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, grade III and low-grade prostate cancer (Gleason score <5 with no metastases)).
  • Have a concurrent disease, medical condition, or extenuating circumstances that, in the opinion of the investigator, might compromise study completion or data collection, including:
  • Localised oral disease, including but not limited to periodontitis, bleeding gums, dysplastic mouth disease.
  • Taking anti-coagulants.
  • Alpha 1 anti-trypsin deficiency.
  • Active infections such as tuberculosis.
  • Conditions that in the opinion of the investigator are not controlled e.g. hypertension, asthma, chronic kidney disease, bowel disease, etc.

Treatment and study plan

AIR-DS

Diagnostic Test

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.

Primary outcomes

  1. Sensitivity

    Time frame: Day 1

    Evaluate the sensitivity of AIR-DS pre-specified algorithm in identifying lung cancer when compared to a clinical diagnosis in a high-incidence lung cancer population.

Secondary outcomes

  1. Specificity, PPV, NPV

    Time frame: Day 1

    Evaluate the specificity, positive and negative predictive values of AIR-DS pre-specified algorithm in identifying lung cancer compared to a clinical diagnosis of lung cancer, in a high-incidence lung cancer population.

  2. Predictive performance of refined predictive algorithm

    Time frame: 12 months after the last participant is recruited

    Predictive performance (e.g. accuracy, sensitivity, specificity, NPV, PPV, AUC) classifying lung cancer as compared with a clinical diagnosis, in a high-risk lung cancer population using the updated algorithm following refinement of the predictive algorithm and cutting points of AIR-DS

  3. Performance of predictive algorithm across lung cancer type and stage

    Time frame: Day 1

    Predictive performance (e.g. accuracy, sensitivity, specificity, NPV, PPV) of AIR-DS pre-specified algorithm compared to a clinical diagnosis of lung cancer in participants with: no lung cancer vs. NSCLC; no lung cancer vs. SCLC; no lung cancer vs. stage 1 lung cancer; and no lung cancer vs. stage 2 lung cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Kim Ibsen

CONTACT

[email protected]

+447930089467

Sponsors and collaborators

Lead sponsor

Sierra Medical Ltd.

Industry

Collaborators

  • Queen Alexandra Hospital

Registry information

Acronym: RADICAL-REACT

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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