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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (2 UK sites)
Northumbria Healthcare NHS Foundation Trust
North Shields, United Kingdom
Queen Alexandra Hospital
Portsmouth PO63LY, United Kingdom
How to Get in Touch
Kim Ibsen
Sponsor contactCONTACT
