Lung CancerNCT07009769
AI-Driven Precision Diagnostic System for Lung Cancer Based on Liquid Biopsy
An observational study of Lung Cancer, run by Korea University Guro Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- How many people
- 865 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult lung cancer patients (≥18 years old) and healthy controls, all South Korean nationals, with plasma collected before any cancer treatment.
Who may be able to join
- 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
- Republic of Korea nationality
- No history of any cancer
- Age ≥ 30 years
Who cannot join
- History of other cancers before blood collection
- Prior cancer treatment before blood collection
- Incomplete clinical data
- No consent for sample use
- History of any malignancy
- Incomplete clinical information or no consent for sample use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Clinical Study for Developing an 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.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective, based on pre-collected samples through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start16 Oct 2024
- Primary completion31 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 865 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Koo Kim, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009769
- Sponsor's protocol ID
- 2024GR0131
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Study for Developing an AI-Driven Precision Diagnostic System for Lung Cancer Based on Liquid Biopsy
- ClinicalTrials.gov ID
- NCT07009769
- Acronym / sponsor ID
- 2024GR0131
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 865 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult lung cancer patients (≥18 years old) and healthy controls, all South Korean nationals, with plasma collected before any cancer treatment.
Key inclusion criteria (7 listed)
- 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
- Republic of Korea nationality
Key exclusion criteria (6 listed)
- History of other cancers before blood collection
- Prior cancer treatment before blood collection
- Incomplete clinical data
- No consent for sample use
- History of any malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.