Cheek‑swab light spectroscopy test for early detection of lung cancer risk

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

This project tests whether a simple cheek swab analyzed with infrared light can help detect early signs of lung cancer in adults who are symptomatic or being investigated for lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sierra Medical Ltd. (Industry-sponsored)
• Locations: 2 sites (North Shields and 1 other locations)
• Trial ID: NCT07051044 on ClinicalTrials.gov

What this trial studies

The study collects a single cheek swab and brief medical history from about 450 adults who are symptomatic or under investigation for possible lung cancer, and analyzes the samples using non‑damaging infrared light spectroscopy (the AIR‑DS technology). The goal is to detect small biochemical changes in inner cheek cells that may indicate elevated lung cancer risk. This is an observational validation effort to compare the spectroscopy findings with routine clinical diagnostic outcomes. All participation involves one clinic visit and no treatment intervention.

Who should consider this trial

Good fit: Adults aged 18 or older who can consent, provide a cheek swab, are symptomatic of or being investigated for lung cancer, and have not started lung cancer treatment are ideal candidates.

Not a fit: People who are pregnant, have had another recent malignancy within five years (with specified exceptions), or who have significant local oral disease that prevents an adequate cheek swab may not benefit from or be eligible for this test.

Why it matters

Potential benefit: If successful, the test could provide a quick, non‑invasive way to flag people at higher risk of lung cancer so they can get diagnostic follow‑up earlier.

How similar studies have performed: Related optical spectroscopy and buccal‑cell biomarker approaches have shown promising signals in small studies, but they are not yet widely validated for clinical use.

Eligibility 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 this trial is running

North Shields and 1 other locations

• Northumbria Healthcare NHS Foundation Trust — North Shields, United Kingdom (Recruiting)
• Queen Alexandra Hospital — Portsmouth, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Kim Ibsen

Conditions Lung Cancer