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RECRUITING
NCT06270992

Oral Microbiome Diagnostics of Lung Cancer

Sponsor: TC Erciyes University

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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)