Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT00636233
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2008-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetics of Spina Bifida and Anencephaly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000757', 'term': 'Anencephaly'}, {'id': 'D009436', 'term': 'Neural Tube Defects'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009008', 'term': 'Abnormalities, Severe Teratoid'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, saliva, cord blood, fetal tissue, cultured fetal cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-31', 'studyFirstSubmitDate': '2008-03-09', 'studyFirstSubmitQcDate': '2008-03-09', 'lastUpdatePostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'genetic factors associated with neural tube defects', 'timeFrame': 'end of the study', 'description': 'This study aims to discover genetic factors associated with neural tube defects such as anencephaly.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anencephaly', 'acrania'], 'conditions': ['Anencephaly', 'Acrania']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://dmpi.duke.edu/anencephaly', 'label': 'Anencephaly study description'}, {'url': 'http://dmpi.duke.edu/neural-tube-defects-ntds', 'label': 'Neural tube defect study description'}]}, 'descriptionModule': {'briefSummary': 'The goal of this research study is to discover the genetic and environmental factors that contribute to the cause of neural tube defects such as spina bifida and anencephaly. Ultimately, this type of research may result in improved diagnosis, improved treatment and possibly prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any current pregnancy affected by anencephaly or acrania.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Not currently enrolling new participants.'}, 'identificationModule': {'nctId': 'NCT00636233', 'briefTitle': 'Genetics of Spina Bifida and Anencephaly', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'The Hereditary Basis of Neural Tube Defects', 'orgStudyIdInfo': {'id': 'Pro00016517'}, 'secondaryIdInfos': [{'id': 'R01NS039818', 'link': 'https://reporter.nih.gov/quickSearch/R01NS039818', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anencephaly', 'description': 'Fetuses with anencephaly, parents and siblings'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Allison Ashley-Koch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}