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Oral Microbiome Diagnostics of Lung Cancer - Trial NCT06270992

Access comprehensive clinical trial information for NCT06270992 through Pure Global AI's free database. This phase not specified trial is sponsored by TC Erciyes University and is currently Recruiting. The study focuses on Lung Cancer. Target enrollment is 676 participants.

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NCT06270992
Recruiting
diagnostic test
Trial Details
ClinicalTrials.gov โ€ข NCT06270992
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Oral Microbiome Diagnostics of Lung Cancer
Developing an Artificial Intelligence-based Diagnostic Method Based on Oral Microbiome for Non-invasive Diagnosis of Lung Cancer

Study Focus

Lung Cancer

NCCN (National Comprehensive Cancer Network) diagnosis

Observational

diagnostic test

Sponsor & Location

TC Erciyes University

Kayseri, Turkey

Timeline & Enrollment

N/A

Nov 15, 2023

May 15, 2026

676 participants

Primary Outcome

Diagnostics accuracy assessment

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.

ICD-10 Classifications

Carcinoma in situ: Bronchus and lung
Secondary malignant neoplasm of lung
Malignant neoplasm of bronchus and lung
Malignant neoplasm: Bronchus or lung, unspecified
Malignant neoplasm: Overlapping lesion of bronchus and lung

Data Source

ClinicalTrials.gov

NCT06270992

Non-Device Trial