Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-19 @ 12:44 PM
Study NCT ID:
NCT06707961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Study of Via Dynamic Change of PCA3 mRNA in Drainage Fluid After Radical Prostatectomy
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'In this study, biospecimens consist of drainage fluid collected from the abdominal cavity of patients following radical prostatectomy. The fluid is obtained through standard post-operative drainage procedures. The collected samples are analyzed to measure the levels of PCA3 mRNA over a designated post-surgical period. The PCA3 mRNA levels in the drainage fluid are dynamically monitored and recorded to assess potential correlations with patient outcomes, recurrence, and metastasis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-09-21', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCA3 mRNA Levels in Drainage Fluid', 'timeFrame': 'Measured daily for up to 3 days post-surgery', 'description': 'PCA3 mRNA Levels in The Drainage Fluid Drained from The Abdominal Cavity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms', 'Exosomes']}, 'descriptionModule': {'briefSummary': 'This study investigates the prognostic value of dynamic changes in PCA3 mRNA levels found in the abdominal cavity drainage fluid after radical prostatectomy. Prostate cancer is one of the most common cancers in men, and radical prostatectomy is a standard treatment. While PSA levels in the blood are commonly used as a marker for diagnosis, this study focuses on the significance of PCA3 mRNA levels in the prognosis of prostate cancer. The findings may provide insights into improved post-surgical monitoring and more tailored therapeutic strategies for prostate cancer patients.', 'detailedDescription': 'This study examines the prognostic significance of PCA3 mRNA levels in the drainage fluid collected from the abdominal cavity following radical prostatectomy, a common surgical treatment for prostate cancer. PSA is widely used as a biomarker for prostate cancer diagnosis, treatment response, and recurrence monitoring in the blood. However, this research seeks to explore the prognostic value of PCA3 mRNA in the drainage fluid. The study involves continuous monitoring of PCA3 mRNA levels in the drainage fluid after radical prostatectomy, with the hypothesis that dynamic changes in these levels could serve as an early warning system for potential tumor recurrence, residual disease, or metastasis. The research will correlate these fluid PCA3 mRNA levels with patient outcomes, recurrence rates, and other clinical factors to determine their predictive value.\n\nBy investigating this novel source of PCA3 mRNA monitoring, the study aims to reduce invasive tests, enhance post-operative surveillance, and improve early detection of disease recurrence for prostate cancer patients. This research could contribute to refining post-surgical care protocols, offering a new tool for predict long-term outcomes for individuals undergoing radical prostatectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include male patients diagnosed with prostate cancer who need radical prostatectomy. Participants must have a preoperative diagnosis confirmed by biopsy and imaging studies. Eligible patients will have an abdominal drainage system in place post-surgery for fluid collection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•Prostate cancer patients treated with radical prostatectomy\n\nExclusion Criteria:\n\n* 1\\. Received neoadjuvant endocrine/chemotherapy before surgery;\n* 2\\. Urine leakage after surgery (positive creatinine test of drainage fluid).'}, 'identificationModule': {'nctId': 'NCT06707961', 'briefTitle': 'Prognostic Study of Via Dynamic Change of PCA3 mRNA in Drainage Fluid After Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Prognostic Study of Prostate Cancer Via Dynamic Change of PCA3 mRNA in Abdominal Cavity Drainage Fluid After Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'YLY-PCA3'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Huaqi Zhan', 'role': 'CONTACT', 'email': '0HuaChang@sjtu.edu.cn', 'phone': '18817532325'}], 'overallOfficials': [{'name': 'Huaqi Zhan', 'role': 'STUDY_CHAIR', 'affiliation': 'https://www.shgh.cn/home/index.html'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Liu Cheng', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}