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Oral Microbiome Diagnostics of Lung Cancer

NCT06270992 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 676

Last updated 2024-02-21

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER

  • TC Erciyes University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2025-02-15
Completion
2026-05-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270992 on ClinicalTrials.gov