Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-28 @ 5:22 AM
Study NCT ID:
NCT03479359
Status:
UNKNOWN
Last Update Posted:
2018-03-27
First Post:
2018-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-02-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-24', 'studyFirstSubmitDate': '2018-03-08', 'studyFirstSubmitQcDate': '2018-03-24', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of DRE performed by internship will be confirmed by prostate biopsy', 'timeFrame': 'One year', 'description': 'To examine the sensitivity and specificity of the DRE performed by internship to reference standard of prostate biopsy in a prospective longitudinal cohort of around 700 participants who will undergo prostate biopsy due to suspect of prostate cancer. The investigators will investigate the sensitivity and specificity of DRE by different internship monthly.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of DRE performed by internship with different training plan will be confirmed by prostate biopsy', 'timeFrame': 'One year', 'description': 'To examine the sensitivity and specificity of the DRE performed by internship (group 1 with routinely review of pathologic outcome of prostate biopsy twice a month, and group 2 internship who are not told the results of prostate biopsy) to standard reference of prostate biopsy.'}, {'measure': 'Sensitivity and specificity of DRE performed by internship will be compared to the results of fPSA/tPSA and MRI.', 'timeFrame': 'One year', 'description': 'To compare the sensitivity and specificity of DRE to fPSA/tPSA and MRI (not any patients are required to have MRI examination of prostate, this will be determined at the discretion of attending doctor) to reference standard of prostate biopsy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate cancer; Benign Prostatic Hyperplasia; Digital Rectal Examination; Accuracy'], 'conditions': ['Prostatic Neoplasms', 'Digital Rectal Examination', 'Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '29061540', 'type': 'BACKGROUND', 'citation': 'Halpern JA, Oromendia C, Shoag JE, Mittal S, Cosiano MF, Ballman KV, Vickers AJ, Hu JC. Use of Digital Rectal Examination as an Adjunct to Prostate Specific Antigen in the Detection of Clinically Significant Prostate Cancer. J Urol. 2018 Apr;199(4):947-953. doi: 10.1016/j.juro.2017.10.021. Epub 2017 Oct 20.'}, {'pmid': '28923535', 'type': 'BACKGROUND', 'citation': 'Clements MB, Schmidt KM, Canfield SE, Gilbert SM, Khandelwal SR, Koontz BF, Lallas CD, Liauw S, Nguyen PL, Showalter TN, Trabulsi EJ, Cathro HP, Schenkman NS, Krupski TL. Creation of a Novel Digital Rectal Examination Evaluation Instrument to Teach and Assess Prostate Examination Proficiency. J Surg Educ. 2018 Mar-Apr;75(2):434-441. doi: 10.1016/j.jsurg.2017.08.012. Epub 2017 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'The investigators conduct this prospective study to investigate the learning curve of digital rectal examination (DRE) for prostate cancer among internship. The investigators want to know how many DRE are usually needed for internship to be performed in urological practice to obtain a stable DRE accuracy.', 'detailedDescription': 'Digital rectal examination (DRE) is a basic physical examination in routine practice in Urology. The DRE is a very important daily practice for screen prostate cancer, and each internship in Urology is required to perform this for patients suspected of prostate cancer or benign prostate hyperplasia. However, how many DRE are usually needed for a internship to perform so as to obtain a stable accuracy in daily practice is currently unknown. The investigators thus conduct this prospective trial to investigate the learning curve of DRE among internship.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All included internship are graduated from the Second Military Medical University and have already get the M.D. degree', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Internship just graduate from the medical school, and agree to attend the study.\n* Internship have less than 5 DREs of prostate cancer.\n* Patients of any age who are included for prostate biopsy are eligible, the indications for prostate biopsy are as follows: PSA\\>4ng/ml, fPSA/tPSA\\<0.16, with suspected palpable nodes in the prostate by DRE of attending doctor, suspected mass in prostate detected by ultrasound examination, magnetic resonance imaging, or computed tomography.\n\nExclusion Criteria:\n\n* Internship who are not willing to attend the study.\n* Internship stop doing DRE for continuously 3 months after entering the study.'}, 'identificationModule': {'nctId': 'NCT03479359', 'briefTitle': 'Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Learning Curve of Digital Rectal Examination for Prostate Cancer Among Internship', 'orgStudyIdInfo': {'id': 'CH-Urology-DRE-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'In this group, internship are given the pathology outcome of each prostate biopsy regularly twice a month.', 'interventionNames': ['Behavioral: Routine review of DRE results by attending doctors']}, {'label': 'Group 2', 'description': 'In this group, internship are not given the pathology outcome of each prostate biopsy.'}], 'interventions': [{'name': 'Routine review of DRE results by attending doctors', 'type': 'BEHAVIORAL', 'description': 'Let the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chuanliang Xu, M.D., Ph.D', 'role': 'CONTACT', 'email': 'drxuchuanliang@126.com', 'phone': '+86 18930568759'}, {'name': 'Yinghao Sun, M.D., Ph.D', 'role': 'CONTACT', 'email': 'sunyhsmmu@126.com'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shuxiong Zeng, M.D., Ph.D', 'role': 'CONTACT', 'email': 'zengshuxiong@126.com', 'phone': '+86 18930568759'}, {'name': 'Xiong Qiao, M.D., Ph.D', 'role': 'CONTACT', 'email': 'xiongqiao1990@126.com', 'phone': '+86 02131161725'}], 'overallOfficials': [{'name': 'Chuanliang Xu, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Military Medical University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'IPD will be shared after the results of the study has been published.', 'ipdSharing': 'YES', 'description': 'IPD will be shared after the results of the study has been published. Related information will be given if request by email is agreed by the principle investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor in the Department of urology', 'investigatorFullName': 'Zeng Shuxiong', 'investigatorAffiliation': 'Changhai Hospital'}}}}