Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT02399761
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2015-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Newborn Screening for Aromatic L-amino Acid Decarboxylase Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537437', 'term': 'Aromatic amino acid decarboxylase deficiency'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154795}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2015-03-21', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of newborns with AADC deficiency', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AADC deficiency, newborn screening'], 'conditions': ['Aromatic L-amino Acid Decarboxylase Deficiency']}, 'descriptionModule': {'briefSummary': 'Parents of newborns will be invited to test if their newborns are affected with Aromatic L-amino Acid Decarboxylase (AADC) deficiency.', 'detailedDescription': 'Parents of newborns will be invited to test if their newborns are affected with Aromatic L-amino Acid Decarboxylase (AADC) deficiency. The routine newborn screening dried blood spots sample will be used to test if 3-O-methyldopa (3-OMD) concentration elevates. If positive of screening test, further confirmation tests including physical examination and for mutation. Genetic counseling and treatment option will be provided, too.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'newborns whose parents agree to be tested', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Babies born in Taiwan receive regular new born screening suggested by Ministry of Heath and Welfare.\n* Parents or Legal Guardian sign in the informed consent form.\n\nExclusion Criteria:\n\n* Parents or Legal Guardian do not agree to sign in the informed consent form.'}, 'identificationModule': {'nctId': 'NCT02399761', 'briefTitle': 'Newborn Screening for Aromatic L-amino Acid Decarboxylase Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Newborn Screening for Aromatic L-amino Acid Decarboxylase Deficiency', 'orgStudyIdInfo': {'id': '201205084RIC'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}