NCT07068139

Brief Summary

This study aims to evaluate the role of artificial intelligence (AI) in predicting disease stage and survival in patients diagnosed with non-small cell lung cancer (NSCLC). Using a retrospective design, the research will analyze radiologic imaging data (PET-CT and chest CT) and corresponding histopathological results of patients who underwent lung cancer surgery at Ondokuz Mayis University Hospital. The goal is to develop and validate a deep learning-based AI model that can automatically assess preoperative radiologic features and estimate postoperative tumor stage and survival outcomes. By integrating radiologic data with confirmed pathological diagnoses, the AI system is expected to provide clinical decision support that can improve diagnostic speed, reduce human error, and help clinicians predict prognosis more accurately. This study does not involve any experimental treatment or prospective follow-up of patients. All data will be collected from existing medical records. The findings may contribute to the digital transformation of healthcare and promote the use of AI tools in thoracic oncology.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
15.5 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 8, 2025

Status Verified

July 1, 2025

Enrollment Period

15.7 years

First QC Date

July 7, 2025

Last Update Submit

August 4, 2025

Conditions

Keywords

Non-Small Cell Lung CancerArtificial IntelligenceDeep LearningRadiologyThoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Development of AI Model for Predicting Tumor Stage and Survival

    The primary outcome of this study is to develop and validate a deep learning-based artificial intelligence model that can predict postoperative tumor stage and survival in patients with non-small cell lung cancer using preoperative PET-CT and chest CT imaging data. The primary outcome will be considered achieved when at least 80% of the planned patient dataset (150 patients) has been successfully included and used for model development.

    From data extraction to completion of model training and validation (estimated by September 2025)

Study Arms (1)

NSCLC Surgery Cohort

This cohort includes patients who were diagnosed with non-small cell lung cancer (NSCLC) and underwent surgical treatment at Ondokuz Mayis University Hospital. Preoperative PET-CT and chest CT images and corresponding postoperative histopathological data were retrospectively collected and analyzed to develop an artificial intelligence model for predicting tumor stage and survival.

Other: AI-Based Predictive Modeling

Interventions

This is not a therapeutic or diagnostic intervention. The study uses a retrospective dataset of radiologic and pathological records to train and validate a deep learning model designed to predict tumor stage and survival in patients with non-small cell lung cancer (NSCLC). No experimental procedure is applied to participants.

Also known as: Deep Learning Algorithm, Retrospective Imaging Analysis
NSCLC Surgery Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study includes patients who underwent surgical treatment for non-small cell lung cancer (NSCLC) at Ondokuz Mayis University Hospital in Samsun, Türkiye. Eligible patients are selected from the hospital's electronic medical records and radiologic imaging archive between January 2010 and March 2025. The population reflects a clinical sample from a tertiary referral center serving a diverse adult patient population in the Black Sea region of Türkiye.

You may qualify if:

  • Age ≥ 18 years
  • Diagnosed with non-small cell lung cancer (NSCLC)
  • Underwent surgical treatment for NSCLC at Ondokuz Mayis University Hospital
  • Available preoperative PET-CT and chest CT imaging
  • Available postoperative histopathological diagnosis and staging
  • Signed informed consent form for data use in research

You may not qualify if:

  • Age \< 18 years
  • No available PET-CT or chest CT imaging in hospital records
  • No available histopathological diagnosis in hospital records
  • Diagnosed with a type of lung cancer other than NSCLC
  • Patients who did not undergo surgery
  • Patients who did not provide informed consent for retrospective data use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Thoracic Surgery Resident

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

January 1, 2010

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

August 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (e.g., imaging features, demographic variables, survival outcomes) may be shared for academic and research purposes upon reasonable request and following institutional data-sharing agreements. No personal identifiers will be included.