Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-03-07 @ 9:03 PM
Study NCT ID:
NCT03123705
Status:
COMPLETED
Last Update Posted:
2019-10-28
First Post:
2017-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
El Paso Public Health Biorepository
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva and blood samples; bacterial and human DNA will be stored'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2017-04-18', 'lastUpdatePostDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation of saliva bio-repository', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'Saliva will be collected from dental patients to be stored for research'}, {'measure': 'The study of oral bacteria', 'timeFrame': 'Through study completion, an average of 3 years', 'description': 'DNA of samples will be analyzed to determine if bacteria play a role in oral health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Disease', 'Bacterial Disease']}, 'descriptionModule': {'briefSummary': 'The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva from children and young adults to study oral infections, markers of inflammation, and other contributors to oral illnesses in Mexican-American individuals.', 'detailedDescription': 'As per summary above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients between the ages of 10-21.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals seen at the City of El Paso dental or pediatric clinics ages 10-21\n* Healthy children and patients that are likely to be seen in the clinics within the predetermined follow-up time of 6 months\n\nExclusion Criteria:\n\n* Patients under 10 years of age and over 21 years of age.'}, 'identificationModule': {'nctId': 'NCT03123705', 'acronym': 'EPB', 'briefTitle': 'El Paso Public Health Biorepository', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University Health Sciences Center, El Paso'}, 'officialTitle': 'TTUHSC El Paso Public Health Biorepository (Research Core Laboratories Dental Biorepository)', 'orgStudyIdInfo': {'id': 'E16076'}}, 'contactsLocationsModule': {'locations': [{'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'overallOfficials': [{'name': 'Peter S Rotwein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University Health Sciences Center, El Paso'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Request for materials should be made after research observations are published in a peer reviewed journal.', 'ipdSharing': 'YES', 'description': 'De-identified information and tissue and body fluid samples will be made available to collaborating academic institutions through material transfer agreements.', 'accessCriteria': 'Institutions studying disease processes in Hispanic populations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University Health Sciences Center, El Paso', 'class': 'OTHER'}, 'collaborators': [{'name': 'The City of El Paso Department of Public Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Peter Rotwein', 'investigatorAffiliation': 'Texas Tech University Health Sciences Center, El Paso'}}}}