Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-02-21 @ 2:53 PM
Study NCT ID:
NCT05323669
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Profile of Thyroid Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D025202', 'term': 'Molecular Diagnostic Techniques'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'histological samples (Formalin Fixed Paraffin Embedded tumour tissue (FFPE)) fixed cytological samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular profile of thyroid nodules', 'timeFrame': '2 years', 'description': 'To develop a molecular profile of thyroid nodules that will allow to distinguish benign from malignant tumor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroid cancer', 'thyroid nodule', 'miRNA', 'molecular testing'], 'conditions': ['Thyroid Cancer', 'Thyroid Nodule']}, 'descriptionModule': {'briefSummary': 'Profiling and comparative analysis of genomic alterations and miRNA expression in benign and malignant thyroid tumors using histological and cytological specimens will be performed. Obtained information is necessary to create a molecular test to refine the cancer risk of cytologically indeterminate thyroid nodules.', 'detailedDescription': 'This is an non-randomised retrospective study consisting of 2 parts. Part A. Histological specimens (formalin fixed paraffin embedded) of patients who were operated on for benign and malignant thyroid disorders will undergo molecular testing to create a molecular profile of thyroid nodules characteristic of Belarusian population.\n\nPart B. Fixed cytological smears of indeterminate thyroid nodules (categories III, IV and V according to Bethesda scoring system) of operated patients will undergo molecular testing to evaluate the possibility and reliability of molecular testing of fixed cytological smears using available assays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population of the Republic of Belarus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients operated on for malignant and benign thyroid tumors. Age is greater than or equal to 18 years old.\n\nExclusion Criteria:\n\nno'}, 'identificationModule': {'nctId': 'NCT05323669', 'acronym': 'MPTN', 'briefTitle': 'Molecular Profile of Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Belarusian State Medical University'}, 'officialTitle': 'Study of Molecular-genetic Profile of Thyroid Nodules', 'orgStudyIdInfo': {'id': '20220367'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Molecular testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Molecular testing of thyroid nodules'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Siarhei U Yakubouski, MD PhD', 'role': 'CONTACT', 'email': 'yakub-2003@yandex.ru', 'phone': '5032186', 'phoneExt': '+37529'}], 'overallOfficials': [{'name': 'Gennadij G Kondratenko, MD PhD Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Belarusian State Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'after summary data are published', 'ipdSharing': 'YES', 'description': 'IPD that underlie results in a publication', 'accessCriteria': 'IPD will be shared through publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belarusian State Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Institute of Genetics and Cytology National Academy of Sciences of Belarus', 'class': 'UNKNOWN'}, {'name': 'Minsk City Clinical Oncologic Centre', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD Assistant Professor', 'investigatorFullName': 'Siarhei Yakubouski', 'investigatorAffiliation': 'Belarusian State Medical University'}}}}