Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-24 @ 5:05 AM
Study NCT ID:
NCT01849835
Status:
UNKNOWN
Last Update Posted:
2014-05-06
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-04', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-05-08', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pain level assessed by visual analogue scale', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'the rate of positive detections', 'timeFrame': '1year'}], 'secondaryOutcomes': [{'measure': 'the incidence rate of each complication', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rate of positive detection'], 'conditions': ['Complication']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Evidence-based Guidelines for Best Practice in Health Care Transrectal Ultrasound Guided Biopsy of the Prostate'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized controlled trial (RCT) is to compare the two ways (tras-rectal and trans-perineal) to perform prostate biopsy from the rate of Positive detection, complications, pain level, operation time and costs et al.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prostate-specific antigen \\> 4ng/ml\n* Palpation is positive\n\nExclusion Criteria:\n\n* older than 80y\n* prostate-specific antigen \\> 100 ng/ml'}, 'identificationModule': {'nctId': 'NCT01849835', 'acronym': 'RCT', 'briefTitle': 'A Test of the Comparison Between Trans-rectal and Trans-perineal Biopsy of Prostate', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'orgStudyIdInfo': {'id': 'tongji10us'}, 'secondaryIdInfos': [{'id': 'tongji10-us1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'trans-rectal', 'description': 'trans-rectal to perform the prostate biopsy', 'interventionNames': ['Procedure: trans-rectal to perform the prostate biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'trans-perineal', 'description': 'trans-perineal to perform the prostate biopsy', 'interventionNames': ['Procedure: trans-perineal to perform the prostate biopsy']}], 'interventions': [{'name': 'trans-rectal to perform the prostate biopsy', 'type': 'PROCEDURE', 'description': 'the puncture points are at the rectal', 'armGroupLabels': ['trans-rectal']}, {'name': 'trans-perineal to perform the prostate biopsy', 'type': 'PROCEDURE', 'otherNames': ['the puncture points are at the perineal'], 'description': 'the puncture points are at the perineal', 'armGroupLabels': ['trans-perineal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'guo lehang, phd', 'role': 'CONTACT', 'email': 'gopp1314@hotmail.com', 'phone': '+8613764538305'}, {'name': 'xu huixiong, phd', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '10Th Hospital of Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'guo lehang, phd', 'role': 'CONTACT', 'email': 'gopp1314@hotmail.com', 'phone': '+8613764538305'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Le-hang Guo', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}