Skip to content

Rapid screening of cheek cells to distinguish cancer using light

Infrared analysis of buccal cell swabs as a novel non-invasive screening test for lung cancer in individuals exposed to carcinogens

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18176235
Enrollment
700
Registered
2022-10-21
Start date
2019-05-01
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) and/or non-small cell lung cancer Respiratory

Interventions

Patients will attend one study visit where the following will be obtained/performed: 1. Informed consent 2. Specific medical history 3. Brief medical history 4. Smoking history 5. Assessment of fo

Sponsors

Sierra Medical
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: There are five arms of the study. Approximately 100 participants will be recruited into the following four groups: A. Non-smokers with no history of lung disease B. Current or ex-smokers with no history of lung disease C. Current or ex-smokers with confirmed COPD D. Current or ex-smokers with lung cancer An additional exploratory group of up to 50 participants will be recruited: E. Smokers and non-smokers with heterogenous lung cancers or suspected lung cancer 1. Are able to understand and provide signed consent – All groups 2. Are aged 18 years or older – All groups 3. Are able to provide a cheek swab sample – All groups 4. Are a non-smoker and never used e-cigarettes – Group A only 5. Are a smoker or ex-smoker – Group B, C and D 6. Must have spirometry of FEV1/FVC ratio >0.7 - Group A and B 7. Are diagnosed with COPD and meet the GOLD criteria for COPD (post-bronchodilator airway obstruction with FEV1/FVC ratio <0.7) Group C only 8. Have (or eventually proven to have) a histologically-confirmed primary non-small cell lung cancer - Group D only 9. Have not commenced treatment for non-small cell lung carcinoma - Group D only 10. Have (or eventually have) a histologically-confirmed cancer a) other than a NSCLC (e.g. small-cell cancer, carcinoid) or b) NSCLC but have never smoked or c) NSCLC but have received treatment – Group E only

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Individual infrared (IR) spectra collected from each participant's cheek cells using a Fourier-transform infrared spectroscopy (FTIR) microspectrometer at a single timepoint

Secondary

MeasureTime frame
Average IR spectra of buccal mucosa swabs measured using a benchtop ATR-FTIR spectrometer for smokers with NSCLC and smokers/non-smokers without NSCLC at a single timepoint

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026