Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-29 @ 5:59 PM
Study NCT ID:
NCT01880203
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2013-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-20', 'studyFirstSubmitDate': '2013-06-14', 'studyFirstSubmitQcDate': '2013-06-14', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the diagnostic performance of the AMC and SWE elastography', 'timeFrame': 'at inclusion, before surgery', 'description': 'Evaluate the diagnostic performance of the AMC and SWE elastography in patients with a thyroid nodule CI taking as reference the histology of the nodule.'}], 'secondaryOutcomes': [{'measure': 'evaluate the diagnostic performance of elastography SWE', 'timeFrame': 'at inclusion, before surgery', 'description': 'For elastography SWE validate decision thresholds for the parameters of elasticity of thyroid nodules, and evaluate the diagnostic performance of elastography SWE combined with those of the standard ultrasound.'}, {'measure': 'Establish a combined diagnostic score results of elastography', 'timeFrame': 'at inclusion, before surgery', 'description': 'Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['thyroid', 'elastography SWE', 'indeterminate cytology'], 'conditions': ['Thyroid Node', 'Indeterminate Cytology', 'Surgery Indication']}, 'referencesModule': {'references': [{'pmid': '32638211', 'type': 'DERIVED', 'citation': 'Bardet S, Goardon N, Lequesne J, Vaur D, Ciappuccini R, Leconte A, Monpeyssen H, Saguet-Rysanek V, Clarisse B, Lasne-Cardon A, Menegaux F, Leenhardt L, Buffet C. Diagnostic and prognostic value of a 7-panel mutation testing in thyroid nodules with indeterminate cytology: the SWEETMAC study. Endocrine. 2021 Feb;71(2):407-417. doi: 10.1007/s12020-020-02411-4. Epub 2020 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (IC) older than 6 months, for which a surgical indication was raised\n\n * vesicular lesion of undetermined significance\n * follicular neoplasm or Hurthle cells\n * lesion suspicious for malignancy\n* Confirmation of indeterminate cytology (IC) replay centralized\n* Patient affiliated to a social security scheme\n* Informed consent and signed\n\nExclusion Criteria:\n\n* Thyroid node \\<15 mm\n* Nodules coalescing preventing proper individualization of targeted nodule\n* Indeterminate cytology older than six months\n* Nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology\n* Major subject to a measure of legal protection or unable to consent\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT01880203', 'acronym': 'SWEETMAC', 'briefTitle': 'Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study', 'orgStudyIdInfo': {'id': 'SWEETMAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aspiration for Molecular Cytogenetic Analysis.', 'interventionNames': ['Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.']}], 'interventions': [{'name': 'aspiration in thyroid node for Molecular Cytogenetic Analysis.', 'type': 'PROCEDURE', 'otherNames': ['cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis.'], 'armGroupLabels': ['aspiration for Molecular Cytogenetic Analysis.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'Centre François BACLESSE', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '14000', 'city': 'Caen', 'state': 'Calvados', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'Hôpital Américain de Paris', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}, {'zip': '75 000', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Pitié-salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation avenir', 'class': 'UNKNOWN'}, {'name': 'laboratoire Genzyme', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}