Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-04 @ 6:14 PM
Study NCT ID:
NCT02702869
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-28
First Post:
2015-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}, {'id': 'D002972', 'term': 'Cleft Palate'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013105', 'term': 'Sphincterotomy, Transduodenal'}, {'id': 'D057909', 'term': 'Orthognathic Surgery'}, {'id': 'D012225', 'term': 'Rhinoplasty'}, {'id': 'D008876', 'term': 'Middle Ear Ventilation'}, {'id': 'D013070', 'term': 'Speech Therapy'}, {'id': 'D009970', 'term': 'Orthodontics'}, {'id': 'D000084982', 'term': 'Nasoalveolar Molding'}, {'id': 'D001299', 'term': 'Audiometry'}, {'id': 'D006310', 'term': 'Hearing Aids'}], 'ancestors': [{'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000074432', 'term': 'Sphincterotomy'}, {'id': 'D000074433', 'term': 'Myotomy'}, {'id': 'D013515', 'term': 'Surgery, Oral'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059747', 'term': 'Nasal Surgical Procedures'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013506', 'term': 'Otologic Surgical Procedures'}, {'id': 'D012049', 'term': 'Rehabilitation of Speech and Language Disorders'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011300', 'term': 'Preoperative Care'}, {'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D006320', 'term': 'Hearing Tests'}, {'id': 'D003939', 'term': 'Diagnostic Techniques, Otological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D012682', 'term': 'Sensory Aids'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '22 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2015-10-16', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech: intelligibility', 'timeFrame': '~5 years of age', 'description': 'Utilizes the intelligibility in context scale (ICS)'}, {'measure': 'Speech: intelligibility', 'timeFrame': '~8 years of age', 'description': 'Utilizes the intelligibility in context scale (ICS)'}, {'measure': 'Speech: intelligibility', 'timeFrame': '~12 years of age', 'description': 'Utilizes the intelligibility in context scale (ICS)'}, {'measure': 'Speech: intelligibility', 'timeFrame': '~22 years of age', 'description': 'Utilizes the intelligibility in context scale (ICS)'}, {'measure': 'Speech: velopharyngeal competence', 'timeFrame': '~5 years of age'}, {'measure': 'Speech: velopharyngeal competence', 'timeFrame': '~8 years of age'}, {'measure': 'Speech: velopharyngeal competence', 'timeFrame': '~12 years of age'}, {'measure': 'Speech: velopharyngeal competence', 'timeFrame': '~22 years of age'}, {'measure': 'Speech: articulation', 'timeFrame': '~5 years of age', 'description': 'Utilizes the modified percent correct consonants (mPCC) scale'}, {'measure': 'Speech: articulation', 'timeFrame': '~8 years of age', 'description': 'Utilizes the modified percent correct consonants (mPCC) scale'}, {'measure': 'Speech: articulation', 'timeFrame': '~12 years of age', 'description': 'Utilizes the modified percent correct consonants (mPCC) scale'}, {'measure': 'Speech: articulation', 'timeFrame': '~22 years of age', 'description': 'Utilizes the modified percent correct consonants (mPCC) scale'}, {'measure': 'Speech: patient-reported outcomes related to speech and speaking', 'timeFrame': '~8 years of age', 'description': 'Utilizes the CLEFT-Q PROM'}, {'measure': 'Speech: patient-reported outcomes related to speech and speaking', 'timeFrame': '~12 years of age', 'description': 'Utilizes the CLEFT-Q PROM'}, {'measure': 'Speech: patient-reported outcomes related to speech and speaking', 'timeFrame': '~22 years of age', 'description': 'Utilizes the CLEFT-Q PROM'}, {'measure': 'Hearing: puretone average', 'timeFrame': '~5 years of age'}, {'measure': 'Dental: dmft and DMFT scores', 'timeFrame': '~5 years of age', 'description': 'Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth'}, {'measure': 'Dental: dmft and DMFT scores', 'timeFrame': '~12 years of age', 'description': 'Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth'}, {'measure': 'Dental: dmft and DMFT scores', 'timeFrame': '~22 years of age', 'description': 'Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth'}, {'measure': 'Dental: occlusion (Uses modifications of the GOSLON scale)', 'timeFrame': '~5 years of age'}, {'measure': 'Dental: occlusion (Uses modifications of the Bauru scale)', 'timeFrame': '~5 years of age'}, {'measure': 'Dental: occlusion (Uses modifications of the GOSLON scale)', 'timeFrame': '~12 years of age'}, {'measure': 'Dental: occlusion (Uses modifications of the Bauru scale)', 'timeFrame': '~12 years of age'}, {'measure': 'Dental: occlusion (Uses modifications of the GOSLON scale)', 'timeFrame': '~22 years of age'}, {'measure': 'Dental: occlusion (Uses modifications of the Bauru scale)', 'timeFrame': '~22 years of age'}, {'measure': 'Dental: patient-reported outcomes related to mastication', 'timeFrame': '~8 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Dental: patient-reported outcomes related to mastication', 'timeFrame': '~12 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Dental: patient-reported outcomes related to mastication', 'timeFrame': '~22 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Dental: patient-reported outcomes related to oral health', 'timeFrame': '~8 years of age', 'description': 'Uses the COHIP PROM'}, {'measure': 'Dental: patient-reported outcomes related to oral health', 'timeFrame': '~12 years of age', 'description': 'Uses the COHIP PROM'}, {'measure': 'Dental: patient-reported outcomes related to oral health', 'timeFrame': '~22 years of age', 'description': 'Uses the COHIP PROM'}, {'measure': 'Patient-reported outcomes related to eating/drinking', 'timeFrame': '~8 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Patient-reported outcomes related to eating/drinking', 'timeFrame': '~12 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Patient-reported outcomes related to eating/drinking', 'timeFrame': '~22 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Breathing: Patient-reported outcomes related to nasal and oral breathing', 'timeFrame': '~8 years of age', 'description': 'Uses the NOSE PROM'}, {'measure': 'Breathing: Patient-reported outcomes related to nasal and oral breathing', 'timeFrame': '~12 years of age', 'description': 'Uses the NOSE PROM'}, {'measure': 'Breathing: Patient-reported outcomes related to nasal and oral breathing', 'timeFrame': '~22 years of age', 'description': 'Uses the NOSE PROM'}, {'measure': 'Aesthetics: Patient-reported outcomes related to appearance', 'timeFrame': '~8 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Aesthetics: Patient-reported outcomes related to appearance', 'timeFrame': '~12 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Aesthetics: Patient-reported outcomes related to appearance', 'timeFrame': '~22 years of age', 'description': 'Uses the CLEFT-Q PROM'}, {'measure': 'Aesthetics: Clinical assessment of nasolabial and facial aesthetics', 'timeFrame': '~2 years of age'}, {'measure': 'Aesthetics: Clinical assessment of nasolabial and facial aesthetics', 'timeFrame': '~5 years of age'}, {'measure': 'Aesthetics: Clinical assessment of nasolabial and facial aesthetics', 'timeFrame': '~8 years of age'}, {'measure': 'Aesthetics: Clinical assessment of nasolabial and facial aesthetics', 'timeFrame': '~12 years of age'}, {'measure': 'Aesthetics: Clinical assessment of nasolabial and facial aesthetics', 'timeFrame': '~22 years of age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cleft lip', 'cleft palate', 'cleft lip and palate', 'cleft alveolus', 'multidisciplinary team', 'interdisciplinary team'], 'conditions': ['Cleft Lip', 'Cleft Palate', 'Cleft Lip and Palate']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.dukehealth.org/pediatric-treatments/pediatric-plastic-and-reconstructive-surgery/cleft-lip-and-cleft-palate', 'label': 'Duke Cleft \\& Craniofacial Center'}, {'url': 'http://www.ichom.org/medical-conditions/cleft-lip-palate/', 'label': 'Official web site for ICHOM Standard Set for cleft lip and/or palate, upon which the Duke project is based'}, {'url': 'http://accquire.net', 'label': 'ACCQUIREnet web site'}]}, 'descriptionModule': {'briefSummary': 'The Allied Cleft \\& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes instruments. Participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and/or palate (CL/P), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.', 'detailedDescription': 'The purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and/or palate (CL/P) treated by the cleft and craniofacial centers that participate in ACCQUIREnet.\n\nAdoption of this prospective data-collection system has two principal goals:\n\n1. To enable on-demand and scheduled review of cleft-care-related safety and outcomes data and team performance for the purpose of internal audits and continuous quality improvement; and\n2. To permit participation in multi-site, collaborative quality-improvement projects and/or research networks that require usage of these standardized data-collection methods. (These collaborations are described in corresponding IRB protocols and data-transfer agreements. Patient privacy and confidentiality is protected at all times.)\n\nAll patients with CL/P treated at cleft and craniofacial centers participating in ACCQUIREnet will be invited to participate in this project. Duke University serves as the coordinating center and statistical support center for the study. Data are maintained in a local, secured database.\n\nThe IRB protocol details methods of quality assurance, data monitoring, and auditing. Data dictionaries employed in ACCQUIREnet include the CleftCap REDCap project template, CleftKit Common Data Model (an extension of the PCORnet Common Data Model), the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients born with cleft lip and/or palate are eligible for inclusion in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Typical orofacial clefts, of which subtypes are:\n* Unilateral or bilateral cleft lip\n* Unilateral or bilateral cleft lip and alveolus\n* Unilateral or bilateral cleft lip and alveolus and palate\n* Unilateral or bilateral cleft lip and palate\n* Overt cleft palate\n* Occult cleft palate\n\nExclusion Criteria:\n\n* Atypical (Tessier) facial clefts'}, 'identificationModule': {'nctId': 'NCT02702869', 'acronym': 'ACCQUIREnet', 'briefTitle': 'Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet): Prospective Data-collection System and Learning Health-care Network for the Comprehensive Appraisal of Cleft and Craniofacial Care', 'orgStudyIdInfo': {'id': 'Pro00104806'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'uCL(A)', 'description': 'Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).', 'interventionNames': ['Procedure: cleft lip repair', 'Procedure: gingivoperiosteoplasty', 'Procedure: LeFort-1 maxillary repositioning', 'Procedure: rhinoplasty', 'Other: speech therapy', 'Procedure: orthodontia', 'Procedure: presurgical orthopedics']}, {'label': 'uCL(A)P', 'description': 'Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III).', 'interventionNames': ['Procedure: cleft lip repair', 'Procedure: cleft palate repair', 'Procedure: oronasal fistula repair', 'Procedure: pharyngoplasty', 'Procedure: gingivoperiosteoplasty', 'Procedure: LeFort-1 maxillary repositioning', 'Procedure: rhinoplasty', 'Procedure: myringotomy and tympanostomy tube placement', 'Other: speech therapy', 'Procedure: orthodontia', 'Procedure: presurgical orthopedics', 'Device: sound amplification for hearing']}, {'label': 'bCL(A)', 'description': 'Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form).', 'interventionNames': ['Procedure: cleft lip repair', 'Procedure: gingivoperiosteoplasty', 'Procedure: LeFort-1 maxillary repositioning', 'Procedure: rhinoplasty', 'Other: speech therapy', 'Procedure: orthodontia', 'Procedure: presurgical orthopedics']}, {'label': 'bCL(A)P', 'description': 'Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV).', 'interventionNames': ['Procedure: cleft lip repair', 'Procedure: cleft palate repair', 'Procedure: oronasal fistula repair', 'Procedure: pharyngoplasty', 'Procedure: gingivoperiosteoplasty', 'Procedure: LeFort-1 maxillary repositioning', 'Procedure: rhinoplasty', 'Procedure: myringotomy and tympanostomy tube placement', 'Other: speech therapy', 'Procedure: orthodontia', 'Procedure: presurgical orthopedics', 'Device: sound amplification for hearing']}, {'label': 'CP', 'description': 'Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II).', 'interventionNames': ['Procedure: cleft palate repair', 'Procedure: oronasal fistula repair', 'Procedure: pharyngoplasty', 'Procedure: LeFort-1 maxillary repositioning', 'Procedure: myringotomy and tympanostomy tube placement', 'Other: speech therapy', 'Device: sound amplification for hearing']}], 'interventions': [{'name': 'cleft lip repair', 'type': 'PROCEDURE', 'otherNames': ['cheiloplasty'], 'armGroupLabels': ['bCL(A)', 'bCL(A)P', 'uCL(A)', 'uCL(A)P']}, {'name': 'cleft palate repair', 'type': 'PROCEDURE', 'otherNames': ['palatoplasty'], 'armGroupLabels': ['CP', 'bCL(A)P', 'uCL(A)P']}, {'name': 'oronasal fistula repair', 'type': 'PROCEDURE', 'armGroupLabels': ['CP', 'bCL(A)P', 'uCL(A)P']}, {'name': 'pharyngoplasty', 'type': 'PROCEDURE', 'otherNames': ['sphincteroplasty'], 'armGroupLabels': ['CP', 'bCL(A)P', 'uCL(A)P']}, {'name': 'gingivoperiosteoplasty', 'type': 'PROCEDURE', 'armGroupLabels': ['bCL(A)', 'bCL(A)P', 'uCL(A)', 'uCL(A)P']}, {'name': 'LeFort-1 maxillary repositioning', 'type': 'PROCEDURE', 'otherNames': ['orthognathic surgery'], 'armGroupLabels': ['CP', 'bCL(A)', 'bCL(A)P', 'uCL(A)', 'uCL(A)P']}, {'name': 'rhinoplasty', 'type': 'PROCEDURE', 'armGroupLabels': ['bCL(A)', 'bCL(A)P', 'uCL(A)', 'uCL(A)P']}, {'name': 'myringotomy and tympanostomy tube placement', 'type': 'PROCEDURE', 'armGroupLabels': ['CP', 'bCL(A)P', 'uCL(A)P']}, {'name': 'speech therapy', 'type': 'OTHER', 'armGroupLabels': ['CP', 'bCL(A)', 'bCL(A)P', 'uCL(A)', 'uCL(A)P']}, {'name': 'orthodontia', 'type': 'PROCEDURE', 'armGroupLabels': ['bCL(A)', 'bCL(A)P', 'uCL(A)', 'uCL(A)P']}, {'name': 'presurgical orthopedics', 'type': 'PROCEDURE', 'otherNames': ['nasoalveolar molding', 'dentofacial orthopedics', 'Georgiade-Latham appliance', 'Latham appliance'], 'armGroupLabels': ['bCL(A)', 'bCL(A)P', 'uCL(A)', 'uCL(A)P']}, {'name': 'sound amplification for hearing', 'type': 'DEVICE', 'otherNames': ['hearing aid'], 'armGroupLabels': ['CP', 'bCL(A)P', 'uCL(A)P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': "Joe DiMaggio Children's Hospital", 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health - Arnold Palmer Hospital for Children', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "Johns Hopkins - All Children's Hospital (JHACH)", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Harvard University - Boston Children's Hospital (BCH)", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Washington University - St. Louis Children's Hospital (WUSTL)", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': "Duke University - Duke Children's Hospital & Health Center", 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': "Wake Forest University - Brenner Children's Hospital", 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "University of Texas at Houston - Children's Memorial Hermann Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Dalhousie University - IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Alexander C Allori, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}