Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-28 @ 6:14 PM
Study NCT ID:
NCT05605067
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2022-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Architecture of Avoidant/Restrictive Food Intake Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080146', 'term': 'Avoidant Restrictive Food Intake Disorder'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000081010', 'term': 'Food Fussiness'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva samples from participants for DNA extraction'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5076}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-25', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Case definitions', 'timeFrame': 'Baseline', 'description': 'Number of enrolled individuals who meet the case definition'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARFID', 'Eating Disorders', 'Eating Disorders in Children', 'Eating, Picky']}, 'referencesModule': {'references': [{'pmid': '37990202', 'type': 'DERIVED', 'citation': 'Bulik CM, Micali N, MacDermod CM, Qi B, Munn-Chernoff MA, Thornton LM, White J, Dinkler L, Pisetsky EM, Johnson J, Devine KR, Ortiz SN, Silverman AE, Berthold N, Dumain A, Guintivano J, Halvorsen M, Crowley JJ. ARFID Genes and Environment (ARFID-GEN): study protocol. BMC Psychiatry. 2023 Nov 21;23(1):863. doi: 10.1186/s12888-023-05266-x.'}, {'pmid': '37693386', 'type': 'DERIVED', 'citation': 'Bulik CM, Micali N, MacDermod CM, Qi B, Munn-Chernoff MA, Thornton LM, White J, Dinkler L, Pisetsky EM, Johnson J, Devine KR, Ortiz SN, Silverman AE, Berthold N, Dumain A, Guintivano J, Halvorsen M, James J. Arfid Genes and Environment (ARFID-GEN): Study Protocol. Res Sq [Preprint]. 2023 Aug 31:rs.3.rs-3186174. doi: 10.21203/rs.3.rs-3186174/v1.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to rapidly accelerate knowledge about the biology of avoidant and restrictive food intake disorder or ARFID in children ages 7-17 and in adults. The investigators will be evaluating the genetic and environmental origins of ARFID. Participants will be asked to answer questionnaires online and to submit a saliva sample for DNA using a kit that will be mailed to their home.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parents of children with ARFID and adults with ARFID will self-select into the study. Because the study is conducted online, participants can join from across the United States', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet study criteria for ARFID\n* Be willing to submit a saliva sample\n* Have a US mailing address\n* English-speaking\n\nExclusion Criteria:\n\n* Potential other eating disorders'}, 'identificationModule': {'nctId': 'NCT05605067', 'acronym': 'ARFID-GEN', 'briefTitle': 'Genetic Architecture of Avoidant/Restrictive Food Intake Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Genetic Architecture of Avoidant/Restrictive Food Intake Disorder', 'orgStudyIdInfo': {'id': '22-1524'}, 'secondaryIdInfos': [{'id': 'R56MH129437', 'link': 'https://reporter.nih.gov/quickSearch/R56MH129437', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Participants will self-select into the study. All enrolled will meet study specific criteria and be considered cases.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Cynthia M Bulik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'Questionnaire data and saliva samples will be submitted to NIMH repositories within 6 months after end of study. Genetic results will be submitted within one year after initial publication. All data will be available after the respective embargo periods.', 'ipdSharing': 'YES', 'description': 'The specimens (saliva and DNA) and data (from questionnaires) may be shared with researchers at UNC or other institutions, such as the National Institutes of Health (NIH), and will eventually be included in the NIH data repository without additional consent. Research studies may be done at many places at the same time. No personal, identifying information will be sent to other researchers or included in the data repository. To secure the data, the NIH data repository will include multiple tiers of data security such as sequential firewalls, independent networks, and encryption based on the content and level of risk associated with the data. All data and information will be submitted to a high security network within NIH through a secure transmission process.\n\nNo participant will be identified in any report or publication about research using their specimens.', 'accessCriteria': 'https://dbgap.ncbi.nlm.nih.gov/aa/dbgap\\_request\\_process.pdf https://nda.nih.gov/nda/access-data-info.html'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'Psychiatric Center Ballerup', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}