Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-01-17 @ 8:55 AM
Study NCT ID:
NCT07039266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Allergy Registry and Awareness Campaign in Puerto Rico
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 151}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Questionnaire', 'timeFrame': '25 min', 'description': 'Demographics Food Allergy Diagnosis Food Allergy Reactions Most Recent Food Allergy Reaction Specific Food Allergy Comorbidities Management Quality of Life Educational Component'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Food Allergy', 'Allergy'], 'conditions': ['Food Allergy Proved']}, 'descriptionModule': {'briefSummary': 'Food Allergies affect 8% of children and 11% of adults, and there are increasing trends worldwide. Suffering food allergies reduces the quality of life and increases ED visits, hospitalizations, and mortality. Minorities in the United States suffer an increased food allergy burden, with higher prevalence, morbidity, and decreased use of preventive measures. Limited information is available in Puerto Rico. Moreover, advances in food allergy diagnostics, prevention, and treatment offer new hope for patients. We aim to develop a de-identified physician-diagnosed food allergy registry in Puerto Rico to characterize the food allergy population demographics, comorbidities, healthcare use, treatment, and quality of life. Our second aim is to educate patients with web-based posts to improve knowledge and awareness of food allergies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Food Allergy age 0 to 100 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* We will recruit Puerto Rican residents aged 0 -100 years diagnosed with food allergies by board-certified allergists. A food allergy diagnosis requires a positive prick skin test or specific IgE and a history of anaphylaxis or the development of cutaneous, respiratory, cardiovascular, or vomiting within 2 hours of ingestion or a positive food challenge.'}, 'identificationModule': {'nctId': 'NCT07039266', 'briefTitle': 'Food Allergy Registry and Awareness Campaign in Puerto Rico', 'organization': {'class': 'OTHER', 'fullName': 'University of Puerto Rico'}, 'officialTitle': 'Food Allergy Registry and Awareness Campaign in Puerto Rico', 'orgStudyIdInfo': {'id': '2502353537A001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Food Allergy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sylvette Nazario, MD', 'role': 'CONTACT', 'email': 'sylvette.nazario@upr.edu', 'phone': '787-448-8420'}, {'name': 'Bonnie Telon Sosa, MPH', 'role': 'CONTACT', 'email': 'bonnie.telon@upr.edu', 'phone': '787-619-5712'}], 'overallOfficials': [{'name': 'Sylvette Nazario, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Puerto Rico - Recinto de Ciencias Médicas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Puerto Rico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}