Oral Microbiome Diagnostics of Lung Cancer

NCT06270992 | Recruiting

• 1 other identifier: 123R030
• Study Type: observational
• Target: 676
• Locations: 1 country
• Sites: 1

Brief 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

Lung Cancer

Keywords

oral microbiome; non-invasive diagnosis; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Diagnostics accuracy assessment

  Diagnostic technology under investigation will be evaluated using sensitivity, specificity, area under receiver operating curve. Cross validation will be used for testing and NCCN diagnosis and patient follow-ups will be considered as the ground truth.

  30 months

Study Arms (3)

Lung cancer group

192 patients diagnosed with lung cancer with the following inclusion criteria: * To be between the ages of 18 and 65, * Not having been previously diagnosed with and treated for lung cancer, * Not having received any cancer treatment in the last 2 years, * Not having been operated on within the last two years, * Not having a hospitalization history in the last year, * Not having used antibiotics in the last six months, * Not having used products manufactured to support the oral microbiome, such as probiotic (lozenges, sublingual drops) for at least the last six months, * Not being pregnant, not breastfeeding, * Not having undergone dental procedures such as root canal treatment, implants, prostheses, tooth extraction, fillings in the last 6 months, Not having dominant immune-origin lesions , viral-origin lesions, dominant bacterial infections like tonsillitis, and/or thermal or chemical mucosal traumas in the mouth.

Diagnostic Test: NCCN (National Comprehensive Cancer Network) diagnosis

Benign lung disease group

192 patients diagnosed with non-cancer diseases with the following inclusion criteria: * To be between the ages of 18 and 65, * To have visited our clinic with complaints related to the lungs and/or respiratory tract, * Not having been diagnosed with lung cancer after clinical evaluation, * Not having received any cancer treatment in the last 2 years, * Not having been operated on within the last two years, * Not having a hospitalization history in the last year, * Not having used antibiotics in the last six months, * Not having used products manufactured to support the oral microbiome, such as probiotics for at least the last six months, * Not being pregnant or breastfeeding, * Not having undergone dental procedures such as root canal treatment, implants, prostheses, tooth extraction, fillings in the last 6 months, * Not having dominant immune-origin lesions, viral-origin lesions, dominant bacterial infections like tonsillitis, and/or thermal or chemical mucosal traumas in the mouth.

Diagnostic Test: NCCN (National Comprehensive Cancer Network) diagnosis

Healthy control group

292 individuals without lung cancer or another lung disease diagnosis with the following inclusion criteria: * To be between the ages of 18 and 65, * Not to have a diagnosed lung disease or suspicion thereof, * Not to have complaints related to the lungs and/or respiratory tract, * Not to have alcohol or severe substance dependency, * Not having a hospitalization history in the last year, * Not having used antibiotics in the last six months, * Not having used products manufactured to support the oral microbiome, such as probiotics (lozenges, sublingual drops) for at least the last six months, * Not being pregnant or breastfeeding, * Not having undergone dental procedures such as root canal treatment, implants, prostheses, tooth extraction, fillings in the last 6 months, * Not having dominant immune-origin lesions, viral-origin lesions, dominant bacterial infections like tonsillitis, and/or thermal or chemical mucosal traumas in the mouth.

Interventions

NCCN (National Comprehensive Cancer Network) diagnosis DIAGNOSTIC_TEST

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.

Benign lung disease group; Lung cancer group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of a lung cancer group of 192 patients, a non-lung cancer benign lung disease group of 192 patients, and 292 healthy controls. Each subgroups are gender and age matched.

You may qualify if:

• To be between the ages of 18 and 65,
• Not to have a diagnosed lung disease or suspicion thereof,
• Not to have complaints related to the lungs and/or respiratory tract,
• Not to have alcohol or severe substance dependency,
• Not having a hospitalization history in the last year,
• Not having used antibiotics in the last six months,
• Not having used products manufactured to support the oral microbiome, such as probiotics (lozenges, sublingual drops) for at least the last six months,
• Not being pregnant or breastfeeding,
• Not having undergone dental procedures such as root canal treatment, implants, prostheses, tooth extraction, fillings in the last 6 months
• Not having dominant immune-origin lesions (such as aphthous ulcers, erythema multiforme, pemphigus), viral-origin lesions (such as herpes, Koplik spots, herpangina), dominant bacterial infections like tonsillitis, and/or thermal or chemical mucosal traumas in the mouth.

Sponsors & Collaborators

• TC Erciyes University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Erciyes University Hospital

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Oral swabs

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Aycan Gundogdu, PhD

CONTACT

+90 352 207 6666; agundogdu@erciyes.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: November 15, 2023
• Primary Completion: February 15, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (1)