Lung CancerRADICAL-REACTNCT07051044
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
An observational study of Lung Cancer, run by Sierra Medical Ltd. at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- AIR-DS
- How many people
- 450 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 2 Jan 2025to 15 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 450 participants will be recruited into the study from at risk or symptomatic patients being evaluated for lung cancer. The study aims to recruit approximately 196 participants with lung cancer. Recruitment will be continually monitored and may be stopped earlier than planned if the investigators have recruited 196 participants with lung cancer and with a sufficient proportion of early-stage lung cancer. Participants who withdraw or are deemed a screen failure will be replaced and will not count towards the overall recruitment.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Northumbria Healthcare NHS Foundation Trust
North Shields
Jessica Reynolds, 0344 811 8111, jessica.reynolds@northumbria-healthcare.nhs.uk
David Cooper
- Recruiting
Queen Alexandra Hospital
Portsmouth, PO63LY
Anoop Chauhan
About this study
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.
Read more
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
- Lung Cancer
- Being tested
- AIR-DS
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIR-DSDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
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.
Measured: Day 1
Secondary outcomes (3)
Specificity, PPV, NPV
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.
Measured: Day 1
Predictive performance of refined predictive algorithm
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
Measured: 12 months after the last participant is recruited
Performance of predictive algorithm across lung cancer type and stage
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start2 Jan 2025
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sierra Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Queen Alexandra Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051044
- Sponsor's protocol ID
- RADICAL-REACT
- Acronym
- RADICAL-REACT
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07051044
- Acronym / sponsor ID
- RADICAL-REACT / RADICAL-REACT
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sierra Medical Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Queen Alexandra Hospital
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 450 participants will be recruited into the study from at risk or symptomatic patients being evaluated for lung cancer. The study aims to recruit approximately 196 participants with lung cancer. Recruitment will be continually monitored and may be stopped earlier than planned if the investigators have recruited 196 participants with lung cancer and with a sufficient proportion of early-stage lung cancer. Participants who withdraw or are deemed a screen failure will be replaced and will not count towards the overall recruitment.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIR-DSAIR-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. | Diagnostic test | – |
Primary outcome
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.
3 secondary outcomes
Specificity, PPV, NPV
Time frame: Day 1
Predictive performance of refined predictive algorithm
Time frame: 12 months after the last participant is recruited
Performance of predictive algorithm across lung cancer type and stage
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Undecided. To be decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Sierra Medical Ltd. at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Ibsen (+447930089467, kim@sierramedical.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.