Using oral microbiome to diagnose lung cancer
Developing an Artificial Intelligence-based Diagnostic Method Based on Oral Microbiome for Non-invasive Diagnosis of Lung Cancer
This study is testing if analyzing the bacteria in your mouth can help doctors tell if someone has lung cancer without needing invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 676 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | TC Erciyes University Academic / other |
| Locations | 1 site (Kayseri) |
| Trial ID | NCT06270992 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a non-invasive diagnostic method for lung cancer by analyzing the oral microbiome through deep learning techniques. An observational cohort of 576 individuals, including lung cancer patients, benign lung disease patients, and healthy controls, will provide tongue swab samples for 16S rRNA sequencing. The project will also incorporate an international cohort of approximately 1700 individuals using in silico data to enhance the analysis. The ultimate goal is to create an AI diagnostic algorithm that can accurately distinguish lung cancer patients from others, tested in a pilot clinical trial with 96 individuals. The study is led by experts in chest surgery, molecular microbiology, and bioinformatics over a 30-month period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 65 who do not have any diagnosed lung diseases or related complaints.
Not a fit: Patients with a history of significant oral health issues or recent antibiotic use may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a non-invasive and easily accessible screening tool for early lung cancer detection.
How similar studies have performed: While studies have explored the relationship between the oral microbiome and lung cancer, this approach using deep learning for diagnostics is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * To be between the ages of 18 and 65, * Not to have a diagnosed lung disease or suspicion thereof, * Not to have complaints related to the lungs and/or respiratory tract, * Not to have alcohol or severe substance dependency, * Not having a hospitalization history in the last year, * Not having used antibiotics in the last six months, * Not having used products manufactured to support the oral microbiome, such as probiotics (lozenges, sublingual drops) for at least the last six months, * Not being pregnant or breastfeeding, * Not having undergone dental procedures such as root canal treatment, implants, prostheses, tooth extraction, fillings in the last 6 months * Not having dominant immune-origin lesions (such as aphthous ulcers, erythema multiforme, pemphigus), viral-origin lesions (such as herpes, Koplik spots, herpangina), dominant bacterial infections like tonsillitis, and/or thermal or chemical mucosal traumas in the mouth. Exclusion Criteria: * Not to satisfy inclusion or declining to participate even though all the inclusion criteria are satisfied.
Where this trial is running
Kayseri
- Erciyes University Hospital — Kayseri, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Aycan Gundogdu, PhD
- Email: agundogdu@erciyes.edu.tr
- Phone: +90 352 207 6666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.