Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06270992

Oral Microbiome Diagnostics of Lung Cancer

Led by TC Erciyes University · Updated on 2024-02-21

676

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

T

TC Erciyes University

Lead Sponsor

T

The Scientific and Technological Research Council of Turkey

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Oral Microbiome Diagnostics of Lung Cancer

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 18 and 65 years old
  • Have no diagnosed lung disease or suspicion of lung disease
  • Have no lung or respiratory tract complaints
  • Not have alcohol or severe substance dependency
  • Have no hospitalization history in the last year
  • Have not used antibiotics in the last six months
  • Have not used oral microbiome support products like probiotics in the last six months
  • Not be pregnant or breastfeeding
  • Have not undergone dental procedures such as root canals, implants, prostheses, tooth extraction, or fillings in the last six months
  • Have no dominant immune-related mouth lesions, viral infections, bacterial infections like tonsillitis, or mouth trauma
Not Eligible

You will not qualify if you...

  • Do not meet all inclusion criteria or decline to participate even if eligible

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Erciyes University Hospital

Kayseri, Turkey (Türkiye), 38039

Actively Recruiting

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Research Team

A

Aycan Gundogdu, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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