Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT01258894
Status:
UNKNOWN
Last Update Posted:
2010-12-22
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Human Alpha-fetoprotein Genes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '10c.c Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-21', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-12-10', 'lastUpdatePostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Elevated or Normal Alpha-fetoprotein Patients']}, 'descriptionModule': {'briefSummary': 'Studies revealed that patients with hereditary persistence of AFP also had persistent abnormal AFP. Therefore, this study will recruit the patients and their family with elevated AFP (\\>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted from the blood will be analyzed.', 'detailedDescription': 'Abnormal AFP elevation was usually noted in liver regeneration, HCC, nonseminomatous germ cell tumors or other malignant tumors. However, some studies revealed that patients with hereditary persistence of AFP also had persistent abnormal AFP. Therefore, we study will recruit the patients and their family with elevated AFP (\\>20 ng/mL) and normal AFP patients being control groups. Then, their AFP genes extracted from the blood will be analyzed. The hypothesis of this study is that the mutation of AFP gene might be one of the causes of abnormal AFP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients and their family with elevated AFP (\\>20 ng/mL) and normal AFP patients being control groups.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients and their family with elevated AFP (\\>20 ng/mL) and normal AFP patients being control groups. More than 20 years old\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01258894', 'briefTitle': 'Investigation of Human Alpha-fetoprotein Genes', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Investigation of Human Alpha-fetoprotein Genes', 'orgStudyIdInfo': {'id': '201010019R'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jin-Chuan Sheu, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'celian0916@yahoo.com.tw', 'phone': '886-2-23123456', 'phoneExt': '66579'}, {'name': 'Jin-Chuan Sheu, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jin Chuan Sheu, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'celian0916@yahoo.com.tw', 'phoneExt': '66579'}], 'overallOfficials': [{'name': 'Jin Chuan Sheu, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jin-Chuan Sheu/ M.D. Ph.D.', 'oldOrganization': 'National Taiwan University Hospital'}}}}