A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy
This study has been completed.
Sponsor:
Samsung Medical Center
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00748514
First received: September 5, 2008
Last updated: October 6, 2008
Last verified: October 2008
| Tracking Information | |||||
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| First Received Date ICMJE | September 5, 2008 | ||||
| Last Updated Date | October 6, 2008 | ||||
| Start Date ICMJE | June 1995 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
biochemical recurrence of prostate cancer [ Time Frame: upto the final date of study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00748514 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
risk factors for capsular incisions [ Time Frame: at surgery ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy | ||||
| Official Title ICMJE | Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy | ||||
| Brief Summary | To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions. |
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| Detailed Description | The pathological classification of the prostate following radical prostatectomy provides important prognostic information; an accurate pathology report is the cornerstone to cancer treatment and follow-up. In addition to the preoperative serum PSA, Gleason score on pathology specimens, seminal vesicle invasion and lymph node status, and a positive surgical margin with extraprostatic extension (EPE) are significant predictors of clinical and biochemical recurrence. However, the prognostic implication of a capsular incision, a tumor extending to the inked margins without a histologically documented EPE, remains to be defined. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: prostate gland |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | the prostate cancer patients treated with radical perineal prostatectomy at single tertiary institution |
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| Condition ICMJE | Radical Perineal Prostatectomy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 266 | ||||
| Completion Date | January 2008 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 43 Years to 78 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00748514 | ||||
| Other Study ID Numbers ICMJE | SMC IRB 2008-08-012, SMC IRB 2008-08-012 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Choi Han Yong, Samsung Medical Center,Sungkyunkwan University School of Medicine | ||||
| Study Sponsor ICMJE | Samsung Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Samsung Medical Center | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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