Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 3:20 PM
Study NCT ID:
NCT04388956
Status:
UNKNOWN
Last Update Posted:
2021-06-09
First Post:
2020-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thyroid Disease Diagnosis by Mutiple Ultrasonic Factors.
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasound evaluation', 'timeFrame': '3 days', 'description': 'Patients who were eligible for this trial will receive the new model of ultrasound evaluation . The traditional features including echogenicity, margin, heterogeneity, size and the presence of microcalcification will be recorded in the same time. Then the investigators evaluate the thyroid tumor vascularity in sagittal and transverse section by power Doppler mode (wall filter (WF): medium, colour power angiography (CPA): 82, retroperitoneal fibrosis (RPF): 1000). The DICOM data of the vascularity index(PDVI) will be collected and analyzed later.'}]}, 'conditionsModule': {'conditions': ['Thyroid', 'Nodule', 'Diagnoses Disease']}, 'descriptionModule': {'briefSummary': 'In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.', 'detailedDescription': '4 to 7 percent of adult population has a palpable thyroid nodule and 17% to 27% of cases can be found when examined by sonography. Although the incidence of the thyroid nodules is high, only 1 of 20 clinically identified nodules is malignant.\n\nSeveral gray scale sonographic characteristics have been suggestive of malignancy, including hypoechoigenicity, micro calcification, blurred margin and intranodular vascularity. The intranodular vascularity has been studied in several researches. But the previous studies usually evaluated the vascularity by color Doppler sonography and only divided into several categories subjectively. And the result is controversial.\n\nThe evaluation of the tumor microcirculation by Doppler ultrasound has been used in many tumors and defined as vascularity index (VI). The power Doppler sonography has many advantages over color Doppler ultrasound in studying the vascularity. It is more sensitive, less noisy. Power Doppler can detect the blood flow of small internal tumor vessels with a diameter of less than 100μm at slow flow rates on the order of a few mm per second1,2 According to our previous study, the vascularity index(PDVI) of thyroid tumor by power Doppler ultrasound between benign and malignant one are statistically different.\n\nIn the present study, the investigators examine different PDVI of thyroid tumors and the traditional（B-mode）ultrasound features including the heterogeneity, echogenicity, margin status, and the presence of microcalcification. The investigators consider the several factors simultaneously by statistical model (PCA, FLD). In the outpatient clinic based population setting, the investigators want to reappraise the accuracy of the new model of multi-factorial ultrasound diagnosis with the conventional fine-needle aspiration cytology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators plan to recruit 300 patients who have discrete solid thyroid tumors need to undergo fine-needle aspiration cytology to provide the tentative diagnosis. The inclusion criteria were discrete thyroid tumors with mainly solid content (\\>50% solid content) and diameter of tumors between 0.5-3cm. The exclusion criteria were abnormal thyroid function, past history of thyroiditis, multinodular goiter, and cystic tumors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have discrete solid thyroid tumors need to undergo fine-needle aspiration cytology to provide the tentative diagnosis\n* discrete thyroid tumors with mainly solid content (\\>50% solid content) and diameter of tumors between 0.5-3cm\n\nExclusion Criteria:\n\n* abnormal thyroid function, past history of thyroiditis, multinodular goiter, and cystic tumors.'}, 'identificationModule': {'nctId': 'NCT04388956', 'briefTitle': 'Thyroid Disease Diagnosis by Mutiple Ultrasonic Factors.', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Diagnosis of Thyroid Tumors by Multiple Ultrasonic Factors.', 'orgStudyIdInfo': {'id': '200805039R'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuen Yuan Chen, MD', 'role': 'CONTACT', 'email': 'dtsurg51@gmail.com', 'phone': '02-23123456', 'phoneExt': '65752'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Kuen-Yuan Chen, MD', 'role': 'CONTACT', 'email': 'dtsurg51@ntuh.gov.tw', 'phone': '886-2-23123456', 'phoneExt': '65752'}], 'overallOfficials': [{'name': 'Kuen-Yuan Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}