Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT05737004
Status:
UNKNOWN
Last Update Posted:
2023-04-19
First Post:
2023-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Prostate Cancer on Brain Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2023-02-12', 'studyFirstSubmitQcDate': '2023-02-12', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The evaluation of Magnetic Resonance(MR)', 'timeFrame': 'Within 1 week before biopsy', 'description': 'To compare the differences in rs-fMRI measures (Amplitude of low frequency fluctuations , Regional Homogeneity and Functional Connectivity ) between prostate cancer group and Non-prostate cancer group.'}], 'secondaryOutcomes': [{'measure': 'Assessment of anxiety status', 'timeFrame': 'Within 1 week before biopsy', 'description': 'Zung Self Rating Anxiety Scale was used to assess anxiety status.By comparing the final score, less than or equal to 10 is considered healthy, and more than 10 is considered abnormal.'}, {'measure': 'Assessment of depressive status', 'timeFrame': 'Within 1 week before biopsy', 'description': 'Beck Depression Inventory-II was used to assess depressive status.By comparing the final scores, a score of 50 or less is considered healthy and a score of 50 or more is considered abnormal.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'functional magnetic resonance imaging(fMRI)', 'Brain function'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'To explore whether the patients with prostate cancer have functional changes in specific brain areas and changes in psychological and mental characteristics compared with the patients without prostate cancer.', 'detailedDescription': 'This study was intended to observe the functional changes of brain fMRI in patients with and without prostate cancer enrolled in the cohort of patients who planned to undergo prostate biopsy, in an attempt to discover specific brain region changes in patients with prostate cancer, and lay a foundation for further clarifying the relationship and mechanism between brain region function changes and prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient coming to our hospital for prostate biopsy and fully understand the clinical trial protocol and sign informed consent', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between the ages of 18 and 80\n2. Patients with prostate biopsy;\n3. No history of other malignant tumors;\n4. Exclude other malignant tumors;\n5. Fully understand the clinical trial protocol and sign informed consent;\n\nExclusion Criteria:\n\n1. magnetic resonance contraindications;\n2. symptomatic acute or chronic inflammation of the prostate;\n3. Patients with brain trauma or brain disease;\n4. Patients who have died of other malignancies in the past or are currently suffering from other malignancies;\n5. Patients judged by the investigator to be unfit to participate in the clinical trial;'}, 'identificationModule': {'nctId': 'NCT05737004', 'briefTitle': 'Effects of Prostate Cancer on Brain Function', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai East Hospital'}, 'officialTitle': 'The Effects of Prostate Cancer on Brain Function: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'EF2023-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prostate cancer group', 'description': 'Prostate cancer was confirmed by biopsy, and fMRI examination 、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II were performed in these patients within 1 week before biopsy .', 'interventionNames': ['Diagnostic Test: functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II']}, {'label': 'Non-Prostate cancer group', 'description': 'Non-Prostate cancer was confirmed by biopsy, and fMRI examination 、 Zung Self Rating Anxiety Scale and Beck Depression Inventory-II were performed in these patients within 1 week before biopsy .', 'interventionNames': ['Diagnostic Test: functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II']}], 'interventions': [{'name': 'functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II', 'type': 'DIAGNOSTIC_TEST', 'description': 'fMRI examination 、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II were performed in these patients within 1 week before biopsy .', 'armGroupLabels': ['Non-Prostate cancer group', 'Prostate cancer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200120', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuaidong Wang, Master', 'role': 'CONTACT', 'email': 'wangshuaidong_wsd@163.com', 'phone': '15102100859'}, {'name': 'Haifeng Wang, MD', 'role': 'CONTACT', 'email': '446720864@qq.com', 'phone': '8613681750891'}], 'facility': 'Shanghai East Hospital, Tongji University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shuaidong Wang', 'role': 'CONTACT', 'email': 'wangshuaidong_wsd@163.com', 'phone': '15102100859'}, {'name': 'Haifeng Wang', 'role': 'CONTACT', 'email': '446720864@qq.com', 'phone': '13681750891'}], 'overallOfficials': [{'name': 'Haifeng Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai East Hospital,Tongji University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available after publication with no end date', 'ipdSharing': 'YES', 'description': 'Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai East Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}