To Explore Racial Differences in Potential Risk Factors for Developing Prostate Cancer in the VA Population.
| Tracking Information | |||||
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| First Received Date ICMJE | December 29, 2000 | ||||
| Last Updated Date | October 16, 2008 | ||||
| Start Date ICMJE | February 1998 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00007579 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 | To Explore Racial Differences in Potential Risk Factors for Developing Prostate Cancer in the VA Population. | ||||
| Official Title ICMJE | Prostate Cancer Case-Control Study: Black Versus White: VA Versus Private Sector | ||||
| Brief Summary | Primary Objectives: To explore racial differences in potential risk factors for developing prostate cancer in the VA population and to compare and contrast the results of this study with that of an ongoing NCI-funded study in North Carolina. Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and whites. To determine whether screening behavior differs in men diagnosed with early stage prostate cancer versus those with later stage disease as well as to determine if screening behavior differences exist between blacks and whites. Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure, and dietary history. Other major endpoints include: 1) familial aggregation of prostate cancer; 2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes, and behaviors about prostate cancer; and 4) treatment choices. Intervention: N/A Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among African Americans the incidence and mortality from prostate cancer is even greater. Although incidence rates in the Southern United States tend to be only slightly higher than that of the nation, a clear discrepancy exists between national mortality rates and those in the Southeastern United States. Notably high rates, particularly among African Americans are observed and in North Carolina the prostate cancer mortality rate among African Americans is the highest of any state in the nation. In spite of these statistics, very little is known about racially based differences in the etiology of this disease. This study hypothesizes that racial differences in the incidence and mortality of prostate cancer may be a result of multiple factors including those that are socioeconomic, environmental, dietary and genetic. This research will provide insight into gene-environmental interactions that initiate and promote prostatic neoplasia as well as address whether there are differences in patterns of care which impact morbidity and survival. The results of this study will also be compared to findings in non-veterans that are being generated through an NCI-funded sister study of these issues under the direction of co-investigator, Dr. JoEllen Schildkraut of Duke University. Subjects were identified from pathology reports extracted from VISTA. Additionally, subjects were identified by reviewing radiation/oncology clinic records for those subjects referred for radiation treatment. Subject enrollment concluded with 100 cases and 98 controls enrolled in the study |
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| Detailed Description | Primary Objectives: To explore racial differences in potential risk factors for developing prostate cancer in the VA population and to compare and contrast the results of this study with that of an ongoing NCI-funded study in North Carolina. Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and whites. To determine whether screening behavior differs in men diagnosed with early stage prostate cancer versus those with later stage disease as well as to determine if screening behavior differences exist between blacks and whites. Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure, and dietary history. Other major endpoints include: 1) familial aggregation of prostate cancer; 2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes, and behaviors about prostate cancer; and 4) treatment choices. Intervention: N/A Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among African Americans the incidence and mortality from prostate cancer is even greater. Although incidence rates in the Southern United States tend to be only slightly higher than that of the nation, a clear discrepancy exists between national mortality rates and those in the Southeastern United States. Notably high rates, particularly among African Americans are observed and in North Carolina the prostate cancer mortality rate among African Americans is the highest of any state in the nation. In spite of these statistics, very little is known about racially based differences in the etiology of this disease. This study hypothesizes that racial differences in the incidence and mortality of prostate cancer may be a result of multiple factors including those that are socioeconomic, environmental, dietary and genetic. This research will provide insight into gene-environmental interactions that initiate and promote prostatic neoplasia as well as address whether there are differences in patterns of care which impact morbidity and survival. The results of this study will also be compared to findings in non-veterans that are being generated through an NCI-funded sister study of these issues under the direction of co-investigator, Dr. JoEllen Schildkraut of Duke University. Subjects are identified from pathology reports extracted from VISTA. It has been determined that pathology reports alone are not a sufficient source of identifying cases because not all patients coming to VA for treatment have diagnostic pathology completed at the Durham VA. Therefore, we have added additional protocols for subject identification such as reviewing radiation/oncology clinic records for those subjects referred for radiation treatment. To-date, 78 cases and 66 controls have been enrolled in the study. To increase accrual rates, in-home visits have been used when necessary, and the Richmond, VA and Asheville, NC VAMCs have been added as participating study sites. Due to patient accrual problems and project staffing changes, the Durham ERIC has granted this study a six-month, no-cost extension through 7/31/2001. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 1 | ||||
| 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 | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Veterans with Prostate Cancer Exclusion Criteria: |
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| Gender | Male | ||||
| Ages | 40 Years to 74 Years | ||||
| 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 | NCT00007579 | ||||
| Other Study ID Numbers ICMJE | 708D | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Walther, Philip - Study Chair, Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | February 2003 | ||||
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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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