Viewing Study NCT00481260


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Study NCT ID: NCT00481260
Status: COMPLETED
Last Update Posted: 2009-09-04
First Post: 2007-05-31
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Characteristics of Hgb C Carriers in Northern Israel and Clinical Features Among Hgb Homozygous
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055991', 'term': 'Health Records, Personal'}], 'ancestors': [{'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-03', 'studyFirstSubmitDate': '2007-05-31', 'studyFirstSubmitQcDate': '2007-05-31', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hgb C', 'Screening'], 'conditions': ['Hgb C Hemoglobinopathy']}, 'descriptionModule': {'briefSummary': 'Hgb C is an hemoglobinopathy quite rare in Israel. The clinical status of patients that are diagnosed as homozygous to this disease is quite benign but not study in large groups.\n\nAlso the characteristics of carriers and the incidence in northern Israel were a large arab population lives, was not study. The results of this study can be useful for screening purpose in a area were another hemoglobinopathies are frequent.', 'detailedDescription': 'Hgb C is an hemoglobinopathy quite rare in Israel. The clinical status of patients that are diagnosed as homozygous to this disease is quite benign but not study in large groups.\n\nAlso the characteristics of carriers and the incidence in northern Israel were a large arab population lives, was not study. The results of this study can be useful for screening purpose in a area were another hemoglobinopathies are frequent.\n\nThe study will record the clinical characteristics of the homozygous Hgb C patients and the hematology characteristics of all the heterozygous carriers detected in northern Israel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed at the pediatric Hematology Unit of laboratory data from the thalassemia screening in northern Israel', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed as homozygous for Hgb C disease or double heterozygous in combination to other abnormal hemoglobin, and all the carriers detected in the hematology laboratory during the screening for abnormal hemoglobins in northern Israel'}, 'identificationModule': {'nctId': 'NCT00481260', 'briefTitle': 'Characteristics of Hgb C Carriers in Northern Israel and Clinical Features Among Hgb Homozygous', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Characteristics of Hgb C Carriers in Northern Israel and Clinical Features Among Hgb Homozygous', 'orgStudyIdInfo': {'id': '5100706.EMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medical history and basic laboratory analysis', 'type': 'PROCEDURE', 'description': 'Medical history and basic laboratory analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Pediatric Hematology Unit - HaEmek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Ariel Koren, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Pediatric Hematology Unit, Ha'Emek Medical Center"}, {'name': 'luci Zalman, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Hematology Laboratory - HaeEmek Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Koren Ariel', 'oldOrganization': 'Pediatric Hematology Unit - HaEmek Medical Center - Afula - Israel'}}}}