Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 9:03 PM
Study NCT ID:
NCT03539692
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood will be collected, additional samples could include sputum, saliva, urine sample, stool sample, oral and nasal samples, skin samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome of standardized food challenges', 'timeFrame': '1 year', 'description': 'Standardized Oral food challenges will occur in a staged manner to diagnose food allergies'}], 'secondaryOutcomes': [{'measure': 'skin testing will occur to evaluate food allergen responses', 'timeFrame': '1 year', 'description': 'Standardized skin testing will be performed to detect sensitivity to food allergens'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Allergy']}, 'referencesModule': {'references': [{'pmid': '30298065', 'type': 'DERIVED', 'citation': "Purington N, Chinthrajah RS, Long A, Sindher S, Andorf S, O'Laughlin K, Woch MA, Scheiber A, Assa'ad A, Pongracic J, Spergel JM, Tam J, Tilles S, Wang J, Galli SJ, Desai M, Nadeau KC. Eliciting Dose and Safety Outcomes From a Large Dataset of Standardized Multiple Food Challenges. Front Immunol. 2018 Sep 21;9:2057. doi: 10.3389/fimmu.2018.02057. eCollection 2018."}]}, 'descriptionModule': {'briefSummary': 'This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '1 Week', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ages 1 wk-90 yrs will be screened and enrolled in this study to determine if they have a clinically-relevant food allergy. If so, they could be eligible for interventional clinical trials in the future.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any individual with possible food allergy (as per their clinical history) who is interested in performing the gold standard food challenge for diagnosis.\n\nExclusion Criteria:\n\n* Any individual who does not consent\n* Any individual who is currently taking oral steroids\n* Any individual with moderate to severe asthma (FEV1\\<80%)'}, 'identificationModule': {'nctId': 'NCT03539692', 'acronym': 'Prescreen', 'briefTitle': 'Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site', 'orgStudyIdInfo': {'id': '34738'}, 'secondaryIdInfos': [{'id': '1UM1AI130839-01', 'link': 'https://reporter.nih.gov/quickSearch/1UM1AI130839-01', 'type': 'NIH'}, {'id': 'FY20ITN384', 'type': 'OTHER_GRANT', 'domain': 'NIH Prime Immune Tolerance Network'}, {'id': '5U19AI104209-07', 'link': 'https://reporter.nih.gov/quickSearch/5U19AI104209-07', 'type': 'NIH'}, {'id': '5UM1AI82034-02', 'type': 'OTHER_GRANT', 'domain': 'NIH Prime Johns Hopkins University'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'SNP Center Inquiry', 'role': 'CONTACT', 'email': 'snpcenterallergy_inquiry@stanford.edu', 'phone': '650-521-7237'}], 'facility': 'The Sean N. Parker Center for Allergy and Asthma Research, Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'SNP Center Inquiry', 'role': 'CONTACT', 'email': 'snpcenterallergy_inquiry@stanford.edu', 'phone': '650-521-7237'}], 'overallOfficials': [{'name': 'Sayantani Sindher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University, SNP Center for Food Allergy and Asthma Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Sayantani B. Sindher', 'investigatorAffiliation': 'Stanford University'}}}}