AI-Driven Precision Diagnostic System for Lung Cancer Based on Liquid Biopsy

The investigators aim to develop an AI-powered precision medicine system based on liquid biopsy that can comprehensively provide lung cancer patients with information on disease stage, histologic subtype, and presence of genetic mutations.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Guro Hospital

Guro-gu, Seoul, 08308, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Patients)

Republic of Korea nationality
Age ≥ 30 years
Lung cancer based on radiologic and/or histopathologic examination
No prior diagnosis of any other cancer and no history of anticancer treatment before the date of blood sample collection

Exclusion criteria

(Patients)

History of other cancers before blood collection
Prior cancer treatment before blood collection
Incomplete clinical data
No consent for sample use

Inclusion criteria

(Healthy Controls):

Republic of Korea nationality
No history of any cancer
Age ≥ 30 years

Exclusion criteria

(Healthy Controls):

History of any malignancy
Incomplete clinical information or no consent for sample use

Treatment and study plan

Primary outcomes

Diagnostic accuracy of the AI-based classification model using SERS signals from plasma-derived exosomes

Time frame: Retrospective, based on pre-collected samples through study completion, an average of 1 year

To evaluate the diagnostic performance (sensitivity, specificity, and overall accuracy) of a machine learning model trained on SERS spectral data of plasma-derived exosomes in distinguishing lung cancer patients from healthy controls.

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

Retrospective Clinical Study for Developing an AI-Driven Precision Diagnostic System for Lung Cancer Based on Liquid Biopsy

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Jun 8, 2025
Registry last updated: Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed