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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.

NCT ID: NCT07051044

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AIR-DS (diagnostic test)
How long the study runs
Study runs about 19 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a quick test that uses light to look at cells swabbed from the inside of the cheek. The test measures how the cells absorb light to spot changes that may help show a person's risk of lung cancer. The study is being run by Sierra Medical Ltd.

Who can take part

  • Aged 18 or over
  • Able to understand the study and sign a consent form (permission to take part)
  • Able to give a swab sample from the inside of the cheek
  • Have symptoms of lung cancer and/or are being tested for lung cancer
  • Have not yet started treatment for lung cancer

Who may not be able to

  • Are pregnant
  • Have been told you have another cancer within the last five years (a few early or low-risk cancers are allowed, such as some skin, cervical and prostate cancers)
  • Have a problem in the mouth, such as gum disease, bleeding gums or abnormal cells in the mouth
  • Take anti-coagulants (blood-thinning medicines)
  • Have a condition called alpha 1 anti-trypsin deficiency
  • Have an active infection such as tuberculosis (TB)
  • Have another illness or circumstance that, in the study team's view, could make it hard to finish the study or collect the information needed, including health problems that are not under control, such as high blood pressure, asthma, long-term kidney disease or bowel disease

What taking part involves

  • • Giving a sample of cells from the inside of your cheek using a swab
  • • The sample is checked with a light-based method called spectroscopy, which measures how the cells absorb light
  • • The test looks for changes in the cheek cells that may help show the risk of lung cancer and help doctors make decisions about next steps

Time commitment: You would give a swab sample from the inside of your cheek; the number of visits and how long the study lasts are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
450
Started
2025-01-02
Last checked
2025-06

Plain English Summary

What is this study?

  • • Testing a new treatment for lung cancer
  • • Clinical study - 450 participants
  • • Overview Sierra Medical is at the forefront of early detection of lung cancer by creating AIR-DS, a non-invasive early detection test

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with lung cancer

Where?

  • • North Shields - Northumbria Healthcare NHS Foundation Trust
  • • Portsmouth - Queen Alexandra Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓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 causing symptoms of, and/or are being investigated for, lung cancer.

Who cannot take part

  • ✗Study participants who meet any of the following criteria will be excluded from participation in this study:
  • ✗Are pregnant.
  • ✗Have a concurrent disease, medical condition, or extenuating circumstances that, in the opinion of the investigator,...
  • ✗Localised oral disease, including but not limited to periodontitis, bleeding gums, dysplastic mouth disease.
  • ✗Taking anti-coagulants.
See the full criteria
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: 1. Localised oral disease, including but not limited to periodontitis, bleeding gums, dysplastic mouth disease. 2. Taking anti-coagulants. 3. Alpha 1 anti-trypsin deficiency. 4. Active infections such as tuberculosis. 5. Conditions that in the opinion of the investigator are not controlled e.g. hypertension, asthma, chronic kidney disease, bowel disease, etc.

Where Is This Study? (2 UK sites)

Northumbria Healthcare NHS Foundation Trust

North Shields, United Kingdom

Recruiting
Site contact (verified)
David CooperPrincipal Investigator

Queen Alexandra Hospital

Portsmouth PO63LY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Joe Shoebridge

research.office@porthosp.nhs.uk023 9228 6236

How to Get in Touch

Kim Ibsen

Sponsor contact

CONTACT

+447930089467 kim@sierramedical.co.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-06