Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-21 @ 12:41 AM
Study NCT ID:
NCT04125667
Status:
UNKNOWN
Last Update Posted:
2019-10-14
First Post:
2019-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culture System for Isolating Circulating Tumor cells_2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-10', 'studyFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2019-10-10', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Circulating Cancer Cells from The Blood Sample', 'timeFrame': 'about 1 week', 'description': 'The number of circulating cancer cells from the blood sample will be investigated. To distinguish cancer cells from blood cells for the system, the lung cancer cells were immunofluorescence stained for Cytokeratin, white blood cells were stained for CD45 and nuclei were counterstained with DAPI.'}], 'secondaryOutcomes': [{'measure': 'Cancer Cell Isolation Efficiency of The Isolation System', 'timeFrame': 'about 1 week', 'description': 'The cell isolation efficiency was characterized by spiking A549 lung cancer cells with celltracker at the concentrations 1000, 100 and 10 cells into whole blood.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circulating cancer cells', 'Biomedical polymer material', 'Cell affinity difference', 'White blood cell attachment'], 'conditions': ['Early Diagnosis', 'Diagnostic Techniques and Procedures']}, 'descriptionModule': {'briefSummary': 'This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating tumor cells from the blood sample. The coating of the system has the characteristic that to make the WBCs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. The supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will include all stages of lung cancer patients between the ages of 20 and 70. Also, to protect the vulnerable subjects, we don't recruit minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with lung cancer are between the ages of 20 and 70\n* Willing to sign the consent form under the informed consent\n\nExclusion Criteria:\n\n* Vulnerable Subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.'}, 'identificationModule': {'nctId': 'NCT04125667', 'briefTitle': 'Culture System for Isolating Circulating Tumor cells_2', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Culture System for Isolating Circulating Tumor Cells', 'orgStudyIdInfo': {'id': '2019071239RINB'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Tai-Horng Young', 'role': 'CONTACT', 'email': 'thyoung@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '81455'}, {'name': 'Yin-Tzu Chen', 'role': 'CONTACT', 'email': 'R07528032@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '81455'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tai-Horng Young', 'role': 'CONTACT', 'email': 'thyoung@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '81455'}, {'name': 'Yin-Tzu Chen', 'role': 'CONTACT', 'email': 'R07528032@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '81455'}], 'overallOfficials': [{'name': 'Tai-Horng Young', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Biomedical Engineering, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}