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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07009769
Enrollment
865
Registered
2025-06-08
Start date
2024-10-16
Completion date
2025-05-01
Last updated
2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Brief summary

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.

Interventions

None listed

Sponsors

Korea University Guro Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of the AI-based classification model using SERS signals from plasma-derived exosomesRetrospective, based on pre-collected samples through study completion, an average of 1 yearTo 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026