Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT07009769
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-Driven Precision Diagnostic System for Lung Cancer Based on Liquid Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 865}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of the AI-based classification model using SERS signals from plasma-derived exosomes', 'timeFrame': 'Retrospective, based on pre-collected samples through study completion, an average of 1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult lung cancer patients (≥18 years old) and healthy controls, all South Korean nationals, with plasma collected before any cancer treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Patients)\n\n* Republic of Korea nationality\n* Age ≥ 30 years\n* Lung cancer based on radiologic and/or histopathologic examination\n* No prior diagnosis of any other cancer and no history of anticancer treatment before the date of blood sample collection\n\nExclusion Criteria (Patients)\n\n* History of other cancers before blood collection\n* Prior cancer treatment before blood collection\n* Incomplete clinical data\n* No consent for sample use\n\nInclusion Criteria (Healthy Controls):\n\n* Republic of Korea nationality\n* No history of any cancer\n* Age ≥ 30 years\n\nExclusion Criteria (Healthy Controls):\n\n* History of any malignancy\n* Incomplete clinical information or no consent for sample use'}, 'identificationModule': {'nctId': 'NCT07009769', 'briefTitle': 'AI-Driven Precision Diagnostic System for Lung Cancer Based on Liquid Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'Retrospective Clinical Study for Developing an AI-Driven Precision Diagnostic System for Lung Cancer Based on Liquid Biopsy', 'orgStudyIdInfo': {'id': '2024GR0131'}}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Guro-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyun Koo Kim', 'investigatorAffiliation': 'Korea University Guro Hospital'}}}}