Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2026-01-02 @ 1:08 PM
Study NCT ID:
NCT05264857
Status:
RECRUITING
Last Update Posted:
2025-10-14
First Post:
2022-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decision Aid and Thyroid Nodules Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-10', 'studyFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of congruence between informed values and treatment choice', 'timeFrame': '6 months from surgery or surgical consultation date', 'description': 'Percent of patients with congruence between treatment option and informed values based on a survey'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Nodule']}, 'descriptionModule': {'briefSummary': 'Patients with small favorable malignant or indeterminate thyroid nodules will receive information about management of thyroid nodules. Participants will be asked to complete brief surveys at the time of enrollment, shortly after the consultation appointment with the surgeon, and a few months after either the consultation or the surgery, to assess their satisfaction with their decision and decision making process. All participants will receive routine care and counseling by their endocrinologist and surgeon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histology showing indeterminate or malignant thyroid pathology (Bethesda III-VI)\n* Thyroid nodule size less or equal to 2cm\n\nExclusion Criteria:\n\n* History of thyroid surgery\n* History of thyroid cancer'}, 'identificationModule': {'nctId': 'NCT05264857', 'briefTitle': 'Decision Aid and Thyroid Nodules Management', 'organization': {'class': 'OTHER', 'fullName': 'Stony Brook University'}, 'officialTitle': 'Decision Aid for Management of Thyroid Nodules and Early Thyroid Cancer', 'orgStudyIdInfo': {'id': 'SBU-DECISION-AID-THYROID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thyroid nodule information', 'interventionNames': ['Behavioral: Thyroid Nodule Management Education']}], 'interventions': [{'name': 'Thyroid Nodule Management Education', 'type': 'BEHAVIORAL', 'description': 'Participants will receive information about thyroid nodules and their management', 'armGroupLabels': ['Thyroid nodule information']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Alfano', 'role': 'CONTACT', 'email': 'jessica.alfano@stonybrookmedicine.edu'}, {'name': 'Caterina Vacchi-Suzzi', 'role': 'CONTACT', 'email': 'caterina.vacchi-suzzi@stonybrookmedicine.edu', 'phone': '6312162993'}, {'name': 'Lukasz Czerwonka, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stony Brook University Cancer Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'centralContacts': [{'name': 'Jessica Alfano', 'role': 'CONTACT', 'email': 'jessica.alfano@stonybrookmedicine.edu', 'phone': '631-216-2993'}, {'name': 'Caterina Vacchi-Suzzi', 'role': 'CONTACT', 'email': 'caterina.vacchi-suzzi@stonybrookmedicine.edu', 'phone': '631-216-2993'}], 'overallOfficials': [{'name': 'Lukasz Czerwonka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lukasz.Czerwonka@stonybrookmedicine.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stony Brook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head and Neck Surgeon', 'investigatorFullName': 'Lukasz Czerwonka', 'investigatorAffiliation': 'Stony Brook University'}}}}