AI-Driven Precision Diagnostic System for Lung Cancer Bas... | NCT07009769

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

NCT07009769

Sponsor

Korea University Guro Hospital

Status

Completed

Last Update Posted

Jun 8, 2025Actual

Enrollment

865Actual

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2024Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

May 1, 2025Actual

First Submitted Date

May 29, 2025

First Submission Date that Met QC Criteria

Jun 5, 2025

First Posted Date

Jun 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2025

Last Update Posted Date

Jun 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

865Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy of the AI-based classification model using SERS signals from plasma-derived exosomes	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.	Retrospective, based on pre-collected samples through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult lung cancer patients (≥18 years old) and healthy controls, all South Korean nationals, with plasma collected before any cancer treatment.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Guro Hospital		Guro-gu	Seoul	08308	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD will not be shared because the data contain sensitive clinical information, and current institutional and ethical guidelines prohibit public sharing of identifiable or potentially re-identifiable participant-level data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided