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NCT06270992Recruiting

Oral Microbiome Diagnostics of Lung Cancer

Developing an Artificial Intelligence-based Diagnostic Method Based on Oral Microbiome for Non-invasive Diagnosis of Lung Cancer
TC Erciyes UniversityClinicalTrials.govdiagnostic test
Verified
Study focus
Disease/Condition
Lung Cancer
Drug/Device/Intervention
NCCN (National Comprehensive Cancer Network) diagnosis
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
TC Erciyes University
Location
Kayseri, Turkey
Timeline & enrollment
Phase
N/A
Start date
Nov 15, 2023
End date
May 15, 2026
Enrollment
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 lungSecondary malignant neoplasm of lungMalignant neoplasm of bronchus and lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm: Overlapping lesion of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06270992
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.