Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT05521594
Status:
COMPLETED
Last Update Posted:
2022-09-26
First Post:
2022-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-23', 'studyFirstSubmitDate': '2022-08-20', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of true positive results of FNAC after thyroidectomy', 'timeFrame': '10 days', 'description': 'Accuracy of FNAC in thyroid nodules compared to to surgical specimen : QOC experience'}, {'measure': 'Percentage of malignant thyroid nodules not observed by FNAC', 'timeFrame': '10 days', 'description': 'type of thyroid malignancy not observed by FNAC'}, {'measure': 'Incidence of false negative results by FNAC', 'timeFrame': '10 days', 'description': 'false negative that diagnosed by FNAC not malignant but proved malignancy after surgical excion'}, {'measure': 'Percentage of Total number of true results of FNAC to the total number of cases', 'timeFrame': '10 days', 'description': 'accuracy of FNAC'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FNAC', 'thyroid nodules', 'thyroidectomy'], 'conditions': ['Fine Needle Aspiration Cytology', 'Thyroid Diseases']}, 'descriptionModule': {'briefSummary': 'Thyroid gland diseases are the second most common endocrine disease following diabetes mellitus(1). Thyroid nodules are common disorders with a prevalence ranged from 4 to 7% in adult population, 5%-30% are malignant \\[1\\].Fine-needle aspiration cytology (FNAC) is an easy, cost-effective test for cancer diagnosis, and its use has markedly decreased the number of unnecessary thyroid surgeries(2).', 'detailedDescription': 'it should be noted that FNAC cannot differentiate between benign and malignant follicular neoplasms.differentiation between follicular adenoma and follicular carcinoma is only possible after thyroid lobectomy.\\[2,3\\] In addition, a study of FNAC showed that 68% of the cases diagnosed by FNAC as follicular neoplasm turned out to be the follicular type of papillary carcinoma, indicting a considerable overlap between benign and malignant neoplasms.\\[4\\] Incidental findings of thyroid nodules have increased exponen¬tially in recent years, mostly due to the widespread application of high-resolution ultrasound (US) to the thyroid \\[5\\].Several in¬ternational scientific societies have established clinic-radiolog¬ical guidelines for the diagnosis and the management of thy¬roid nodules \\[2,3\\]. The American College of Radiology identifies 5 radiological risk levels and recommends US-guided fine-nee¬dle aspiration cytology (US-FNAC) of high-suspicion nodules if 10 mm or larger, and of nodules with a low risk for malignan¬cy only if larger than 25 mm \\[2\\]. According to the European Thyroid Association Guidelines (EU-TIRADS), nodules with no high-risk features (oval-shaped, isoechoic/hyperechoic with smooth margins) should be considered at low risk and FNA performed only if greater than 20 mm, while high-risk nodules greater than 10 mm should undergo FNAC, with possible FNAC also in 5-10 mm nodules if highly suspicious \\[3\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thyroid diseases\n* Multi nodullar\n* single nodules\n* diffuse goiter\n* Thyroid diseases underwent FNAC Then Thyroid surgery\n\nExclusion Criteria:\n\n* Patients with no diagnostic FNAC'}, 'identificationModule': {'nctId': 'NCT05521594', 'acronym': 'Thyroid FNAC', 'briefTitle': 'Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Qena Oncology Center'}, 'officialTitle': 'Accuracy of FNAC in Thyroid Nodules Compared to to Surgical Specimen : QOC Experience', 'orgStudyIdInfo': {'id': 'Qena Oncology Center 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FNAC', 'interventionNames': ['Procedure: Fine Needle Aspiration Cytology']}, {'type': 'EXPERIMENTAL', 'label': 'post operative hitopathology', 'interventionNames': ['Procedure: Fine Needle Aspiration Cytology']}], 'interventions': [{'name': 'Fine Needle Aspiration Cytology', 'type': 'PROCEDURE', 'otherNames': ['Thyrodectomy'], 'description': 'Comparison between FNAC and post operative specimen after thyroid surgery', 'armGroupLabels': ['FNAC', 'post operative hitopathology']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+2', 'city': 'Qina', 'country': 'Egypt', 'facility': 'Qena Oncology Center', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'overallOfficials': [{'name': 'Amr M Makky, specialist surgical onclogy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qena Oncology Center- Medical Military Academy'}, {'name': 'Abdullah Atyah Ali, Ass.Lecture General Surgery', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qena Oncology Center--Luxor University'}, {'name': 'Mohamed Ahmed Orabi, specialist surgical onclogy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qena Oncology Center'}, {'name': 'Mina Romany Tawfeek', 'role': 'STUDY_CHAIR', 'affiliation': 'Qena Oncology Center'}, {'name': 'Mahmoud Ahmed Dosoky, specialist pathology', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Qena Oncology Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qena Oncology Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist of surgical oncology at Qena Oncology Center', 'investigatorFullName': 'Mohamed Ahmed Orabi', 'investigatorAffiliation': 'Qena Oncology Center'}}}}