Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-04-08 @ 12:52 PM
Study NCT ID:
NCT03039335
Status:
COMPLETED
Last Update Posted:
2018-07-16
First Post:
2017-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Delayed Diagnosis of Alpha-1 Antitrypsin Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-13', 'studyFirstSubmitDate': '2017-01-31', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': '3 months', 'description': 'Track the number of subjects enrolled to determine if recruitment strategies need to be altered.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alpha 1-Antitrypsin Deficiency']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to prospectively assess whether there is any interval between first symptom and initial diagnosis that is experienced by patients with newly diagnosed alpha-1 antitrypsin deficiency (AATD) and then to assess whether this diagnostic interval is associated with worsened clinical status at the time of initial diagnosis.', 'detailedDescription': 'The study protocol proposes to assess participants\' clinical status based on the results of spirometry tests that are performed by the patient\'s managing physician as a routine part of clinical care of individuals with AATD within +/- 6 months of the initial diagnosis, subjects\' St. George\'s Respiratory Questionnaire (SGRQ) at the time of initial diagnosis, and their COPD Assessment Test (CAT) result at the time of initial diagnosis of AATD (hereafter called "time zero" or T0 defined as the day on which the patient\'s test shows AATD from the blood work submitted for testing to Biocerna LLC by the patients\' managing physicians as part of their routine clinical management). After offering verbal consent, subjects will complete a survey that assesses various clinical domains, including demographic features, how was AATD ascertained, initial symptom ascribable to AATD, the number of healthcare providers (and specific types of providers) seen before initial diagnosis, and clinical status at T0 or within a defined, relatively narrow temporal window (+/- 6 months) of T0. As in prior studies, the diagnostic interval will be defined as the duration between self-reported initial symptom of AATD (usually dyspnea in \\> 80% of cases3) and initial confirmed diagnosis of AATD (T0).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'AATD Positive Adult Subjects', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Positive AATD Test Result\n\nExclusion Criteria:\n\n* Previous Positive AATD Test Result\n* Negative Test Result for AATD'}, 'identificationModule': {'nctId': 'NCT03039335', 'briefTitle': 'The Impact of Delayed Diagnosis of Alpha-1 Antitrypsin Deficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocerna LLC'}, 'officialTitle': 'The Impact of Delayed Diagnosis of Alpha-1 Antitrypsin Deficiency: Assessing the Association Between Diagnostic Delay and Worsened Clinical Status', 'orgStudyIdInfo': {'id': '16001'}, 'secondaryIdInfos': [{'id': 'Pro00019289', 'type': 'OTHER', 'domain': 'Chesapeake IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with an AAT Deficiency', 'description': 'Subjects over the age of 18 that have been recently diagnosed with an Alpha-1 Antitrypsin deficiency will be enrolled into the study to observe the interval between first symptom and initial diagnosis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20759', 'city': 'Fulton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Biocerna LLC', 'geoPoint': {'lat': 39.15094, 'lon': -76.92303}}], 'overallOfficials': [{'name': 'Christopher Sanders', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CEO of Biocerna LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocerna LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}