Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-28 @ 4:29 PM
Study NCT ID:
NCT06026735
Status:
RECRUITING
Last Update Posted:
2023-09-07
First Post:
2022-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-small Cell Lung Cancer With Central Nervous System Metastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2023-09-04', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'predict lung cancer metastasis and Bioindicators of treatment effect', 'timeFrame': 'follow 3 years', 'description': 'Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer With Central Nervous System Metastasis']}, 'descriptionModule': {'briefSummary': 'Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Non-small cell lung cancer patients with brain metastases or meningeal metastases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- A. Non-small cell lung cancer patients diagnosed with brain metastases or meningeal metastases on brain computed tomography (CT) or magnetic resonance (MRI) images.\n\nB. Patients with non-small cell lung cancer who are about to undergo surgical brain surgery, such as brain tumor resection, lumbar abdominal drainage, Euclidean storage, or ventriculoperitoneal drainage.\n\nExclusion Criteria:\n\n\\- A. Non-small cell lung cancer patients without brain metastases or meningeal metastases.\n\nB. Physical condition does not allow surgical removal of the tumor.'}, 'identificationModule': {'nctId': 'NCT06026735', 'briefTitle': 'Non-small Cell Lung Cancer With Central Nervous System Metastasis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comprehensive Profiling of Promising Biomarkers in Exosomes From Non-small Cell Lung Cancer With Central Nervous System Metastasis', 'orgStudyIdInfo': {'id': '202209032RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lung cancer with brain metastasis', 'interventionNames': ['Other: lung cancer with brain /leptomeningeal metastasis']}, {'label': 'lung cancer with leptomeningeal metastasis', 'interventionNames': ['Other: lung cancer with brain /leptomeningeal metastasis']}], 'interventions': [{'name': 'lung cancer with brain /leptomeningeal metastasis', 'type': 'OTHER', 'description': 'Cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. Then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and Bioindicators of treatment effect.', 'armGroupLabels': ['lung cancer with brain metastasis', 'lung cancer with leptomeningeal metastasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'ABEL HUANG', 'role': 'CONTACT', 'email': 'how.how0622@gmail.com', 'phone': '023123456', 'phoneExt': '265913'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'ABEL HUANG, MD', 'role': 'CONTACT', 'email': 'how.how0622@gmail.com', 'phone': '+8860223123456', 'phoneExt': '265913'}, {'name': 'ABEL HUANG', 'role': 'CONTACT', 'email': 'how.how0622@gmail.com', 'phone': '+8860223123456', 'phoneExt': '265913'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}