Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-06 @ 12:04 AM
Study NCT ID:
NCT02561533
Status:
COMPLETED
Last Update Posted:
2017-07-14
First Post:
2015-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}], 'ancestors': [{'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-13', 'studyFirstSubmitDate': '2015-09-17', 'studyFirstSubmitQcDate': '2015-09-25', 'lastUpdatePostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunohistochemical detection of BRAF mutation on fine needle aspiration biopsy (FNAB)', 'timeFrame': '1 day', 'description': 'Mutations status correlated to histological diagnoses and mutation status on histological samples'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Papillary Thyroid Carcinoma']}, 'descriptionModule': {'briefSummary': 'Immunohistochemical detection of the BRAF-V600E mutation on pre-operative fine needle aspiration biopsy (FNAB) from patients suspected for papillary thyroid carcinoma, using the mutation specific antibody VE1.', 'detailedDescription': 'The BRAF mutation is reported to be present in approximately 50% of papillary thyroid carcinomas (PTC). The mutation has been associated with poor prognosis and more advanced disease stage. Therefore, pre-operative detection of the BRAF-V600E mutation may be of clinical interest in order to individualize treatment of patients with BRAF positive PTC.\n\nFNABs are performed immediately before the thyroid operation, and BRAF-V600E detection using VE1 is performed on clots. The VE1 stain is compared to the mutation status of the removed cancer or control tissue using the Cobas test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (\\>1cm)\n* Undergoing thyroid surgery (histology of index nodule)\n\nExclusion Criteria:\n\n* Not undergoing thyroid surgery'}, 'identificationModule': {'nctId': 'NCT02561533', 'briefTitle': 'Detection of BRAF Mutation on FNAB From Papillary Thyroid Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Immunohistochemical Detection of the BRAFV600E Mutation on Cytological Specimen in PTC', 'orgStudyIdInfo': {'id': 'TIHCDBMTC1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BRAF immunohistochemistry (IHC)', 'interventionNames': ['Other: BRAF detection on fine needle aspiration biopsy (FNAB)']}], 'interventions': [{'name': 'BRAF detection on fine needle aspiration biopsy (FNAB)', 'type': 'OTHER', 'armGroupLabels': ['BRAF immunohistochemistry (IHC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD-student', 'investigatorFullName': 'Kristine Zøylner Rubeck', 'investigatorAffiliation': 'University of Aarhus'}}}}