Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up
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| First Received Date ICMJE | April 1, 2010 | ||||
| Last Updated Date | January 9, 2013 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01098552 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up | ||||
| Official Title ICMJE | Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up | ||||
| Brief Summary | This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer. This study is also being done to relate treatment outcome to measurement of substances in the blood such as prostate-specific antigen (PSA) and other markers. Also environmental and genetic factors that might be responsible for prostate cancer are being investigated. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood, urine, prostate tissue |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | There are six patient cohorts which are being recruited to the Prostate Clinical Follow-up Core in support of the Specialized Program of Research Excellence (SPORE). The six groups are: 1. High-risk radical prostatectomy patients, 2. Primary external beam radiotherapy patients, 3. Primary prostate brachytherapy patients, 4. Hormone refractory prostate cancer patients, 5. Active Surveillance. 6. Prostate biopsy patients. The inclusion criterion for group 6 is that the patient is scheduled to undergo a prostate biopsy for the purposes of definitive prostate cancer diagnosis. There are no exclusion criteria for group 6. |
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| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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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 | 4900 | ||||
| Completion Date | November 2012 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01098552 | ||||
| Other Study ID Numbers ICMJE | 1937-00, Mayo Clinic Prostate SPORE | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Robert Karnes, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | January 2013 | ||||
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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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