Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
Study NCT ID:
NCT03843450
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2019-02-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Culture System for Isolating Circulating Tumor Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-09-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer Cell Isolation Efficiency of The Isolation System', 'timeFrame': '1 day', 'description': 'The percentage isolation of fluorescently-labeled A549 cell lines will be spiked into the whole blood, and the put into the system. The supernatant of the system will be collected to re-culture on the culture dishes and analyzed by fluorescence microscope.'}, {'measure': 'WBCs adhesion ratio', 'timeFrame': '1 hour', 'description': 'The whole blood will be diluted and put into the system. And the supernatant will be collected to count the number of blood cell number by the automatic blood cell count.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['circulating tumor cells,WBCs adhesion, biomedical materials'], 'conditions': ['Early Detection of Cancer']}, 'descriptionModule': {'briefSummary': 'This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating cancer 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 polycythemia patients between the ages of 20 and 70. We just use the waste blood from patients' routine phlebotomy therapy. 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\n1. Polycythemia patients are between the ages of 20 and 70.\n2. Willing to sign the consent form under the informed consent.\n\nInclusion Criteria:\n\nExclusion Criteria:\n\n1\\. Vulnerable Subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.'}, 'identificationModule': {'nctId': 'NCT03843450', 'briefTitle': 'Culture System for Isolating Circulating Tumor Cells', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Culture System for Isolating Circulating Tumor Cells', 'orgStudyIdInfo': {'id': '201811053RINA'}}, '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': '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': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Biomedical Engineering, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}