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Oral Microbiome Diagnostics of Lung Cancer
Sponsor: TC Erciyes University
Summary
The study aims to develop a deep learning-based diagnostic method for lung cancer using the oral microbiome. This innovative approach involves establishing an observational cohort of 576 individuals, including lung cancer patients, non-cancerous benign lung disease patients, and healthy controls, to collect tongue swab samples for 16S rRNA sequencing. Additionally, an international cohort of approximately 1700 individuals will be formed using in silico data. The project will utilize deep learning methods to analyze all data integratively and develop an AI diagnostic algorithm capable of distinguishing lung cancer patients from others. The diagnostic method's performance will be tested in a pilot clinical trial with 96 individuals using a PRoBE design. Led by experts in chest surgery, molecular microbiology, and bioinformatics, the project spans over 30 months and aims to create a non-invasive, easily accessible lung cancer screening method that could lead to significant diagnostic advancements and potential spin-off companies in the field of liquid biopsy/molecular diagnosis.
Official title: Developing an Artificial Intelligence-based Diagnostic Method Based on Oral Microbiome for Non-invasive Diagnosis of Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
OBSERVATIONAL
Enrollment
676
Start Date
2023-11-15
Completion Date
2026-05-15
Last Updated
2024-02-21
Healthy Volunteers
Yes
Conditions
Interventions
NCCN (National Comprehensive Cancer Network) diagnosis
For diagnostic evaluation, the necessary procedures from the standard protocols consisting of anamnesis, physical examination, laboratory tests, radiological imaging methods, and tissue biopsy will be followed. Computerized Tomography (CT) and Positron Emission Tomography-Computed Tomography (PET-CT) will be used as imaging methods, while fiberoptic bronchoscopy and video-assisted mediastinoscopy will be applied for tissue diagnosis and staging.
Locations (1)
Erciyes University Hospital
Kayseri, Turkey (Türkiye)