Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-08 @ 1:38 AM
Study NCT ID:
NCT00595660
Status:
UNKNOWN
Last Update Posted:
2008-01-16
First Post:
2008-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}], 'ancestors': [{'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2008-01-15', 'studyFirstSubmitDate': '2008-01-07', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'specimen adequacy', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'complication', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Palpable Breast Mass', 'FNA', 'Cytology', 'Fine needle aspiration', 'Specimen Adequacy'], 'conditions': ['Palpable Breast Mass']}, 'descriptionModule': {'briefSummary': 'Needle size from22 to 25 were used for fine needle aspiration of palpable breast lumps. In this study we choose one, randomly, and fallow the result of cytologic evaluation regarding specimen adequacy.', 'detailedDescription': 'Patient assigned randomly to FNA of palpable breast mass with different needle size:21-22-23-24'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any Woman with palpable Breast Mass\n\nExclusion Criteria:\n\n* Previous open Biopsy or Surgery\n* Active infection\n* Breast cysts\n* Patient refusal to do FNA'}, 'identificationModule': {'nctId': 'NCT00595660', 'briefTitle': 'Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Kashani Social Security Hospital'}, 'officialTitle': 'Best Needle Size for FNA of Palpable Breast Mass:Randomised Controlled Study', 'orgStudyIdInfo': {'id': '17251-10/10/1386'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Needle 21 for FNA', 'interventionNames': ['Procedure: FNA - fine needle aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '22 needle for FNA', 'interventionNames': ['Procedure: FNA - fine needle aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '23 needle for FNA', 'interventionNames': ['Procedure: FNA - fine needle aspiration']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': '24 needle for FNA', 'interventionNames': ['Procedure: FNA - fine needle aspiration']}], 'interventions': [{'name': 'FNA - fine needle aspiration', 'type': 'PROCEDURE', 'description': 'Fine Needle aspiration', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'FNA - fine needle aspiration', 'type': 'PROCEDURE', 'description': 'Fine needle aspiration', 'armGroupLabels': ['1']}, {'name': 'FNA - fine needle aspiration', 'type': 'PROCEDURE', 'description': 'Fine needle aspiration', 'armGroupLabels': ['2']}, {'name': 'FNA - fine needle aspiration', 'type': 'PROCEDURE', 'description': 'Fine needle aspiration', 'armGroupLabels': ['3']}, {'name': 'FNA - fine needle aspiration', 'type': 'PROCEDURE', 'description': 'Fine needle aspiration', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'contacts': [{'name': 'Bijan Mohammadhosseini, General Surgeon,MD', 'role': 'CONTACT', 'email': 'bijanmh@Gmail.com', 'phone': '+989121009677'}], 'facility': 'Kashani Social Security Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Bijan -- Mohammadhosseini, General Surgeon,MD', 'role': 'CONTACT', 'email': 'bijanmh@Gmail.com', 'phone': '+989121009677'}], 'overallOfficials': [{'name': 'Bijan Mohammadhosseini, General Surgeon,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kashani Social Security Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kashani Social Security Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr.Hamidzadeh', 'oldOrganization': 'Kashani Social Security Hospital'}}}}