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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01252 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue
PRIMARY OBJECTIVES:
I. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SBRT for localized prostate cancer.
SECONDARY OBJECTIVES:
I. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC) and American Urological Association (AUA) scores.
II. Assess biochemical control after high-dose SBRT.
OUTLINE:
Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months, every 6 months for 4 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (SBRT) | Experimental | Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiation therapy | Radiation | Undergo SBRT |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 | Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0 | 1.5 months |
| Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 | Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0 | 4 months |
| Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 | Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0 | 8 months |
| Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 | Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Assessed by EPIC Scores | Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Baseline and 1.5 months |
| Quality of Life as Assessed by EPIC Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Stephans | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32349020 | Derived | Parsai S, Juloori A, Sedor G, Reddy CA, Thousand R, Magnelli A, Berglund RK, Stovsky M, Klein EA, Tendulkar RD, Stephans KL. Heterogenous Dose-escalated Prostate Stereotactic Body Radiation Therapy for All Risk Prostate Cancer: Quality of Life and Clinical Outcomes of an Institutional Pilot Study. Am J Clin Oncol. 2020 Jul;43(7):469-476. doi: 10.1097/COC.0000000000000693. |
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Subjects were recruited from regional hospitals from July 2012 thru Jan 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (SBRT) | Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| laboratory biomarker analysis | Other | Correlative studies |
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Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. |
| Baseline and 4 months |
| Quality of Life as Assessed by EPIC Scores | Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Baseline and 8 months |
| Quality of Life as Assessed by EPIC Scores | Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Baseline and 12 months |
| Quality of Life as Assessed by Change in AUA Scores | Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment. | Baseline and 1.5 months |
| Quality of Life as Assessed by Change in AUA Scores | Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment. | Baseline and 4 months |
| Quality of Life as Assessed by Change in AUA Scores | Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment. | Baseline and 8 months |
| Quality of Life as Assessed by Change in AUA Scores | Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment. | Baseline and 12 months |
| Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA | Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir. | Baseline and 1.5 months |
| Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA | Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir. | Baseline and 4 months |
| Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA | Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir. | Baseline and 8 months |
| Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA | Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir. | Baseline and 12 months |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (SBRT) | Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 | Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0 | All patients that received treatment | Posted | Count of Participants | Participants | 1.5 months |
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| Primary | Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 | Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0 | Per protocol | Posted | Count of Participants | Participants | 4 months |
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| Primary | Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 | Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0 | Per protocol | Posted | Count of Participants | Participants | 8 months |
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| Primary | Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 | Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0 | All patients that received treatment | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Quality of Life as Assessed by EPIC Scores | Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Participants that were able to complete the questionnaire at specific time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 1.5 months |
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| Secondary | Quality of Life as Assessed by EPIC Scores | Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Participants that were able to complete the questionnaire at specific time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 4 months |
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| Secondary | Quality of Life as Assessed by EPIC Scores | Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Participants that were able to complete the questionnaire at specific time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 months |
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| Secondary | Quality of Life as Assessed by EPIC Scores | Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment. | Participants that were able to complete the questionnaire at specific time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months |
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| Secondary | Quality of Life as Assessed by Change in AUA Scores | Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment. | Participants that were able to complete the questionnaire at specific time point. | Posted | Median | Full Range | score on a scale | Baseline and 1.5 months |
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| Secondary | Quality of Life as Assessed by Change in AUA Scores | Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment. | Participants that were able to complete the questionnaire at specific time point. | Posted | Median | Full Range | score on a scale | Baseline and 4 months |
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| Secondary | Quality of Life as Assessed by Change in AUA Scores | Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment. | Participants that were able to complete the questionnaire at specific time point. | Posted | Median | Full Range | score on a scale | Baseline and 8 months |
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| Secondary | Quality of Life as Assessed by Change in AUA Scores | Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment. | Participants that were able to complete the questionnaire at specific time point. | Posted | Median | Full Range | score on a scale | Baseline and 12 months |
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| Secondary | Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA | Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir. | participants who had a PSA values up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 1.5 months |
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| Secondary | Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA | Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir. | participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 4 months |
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| Secondary | Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA | Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir. | participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 8 months |
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| Secondary | Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA | Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir. | participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and 12 months |
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Adverse event data collect from participants up to 1 year in follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (SBRT) | Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies | 1 | 35 | 1 | 35 | 34 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Weight gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Stephans MD | Case Comprehensive Cancer Center | 216-445-8285 | stephak@ccf.org |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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| Title | Measurements |
|---|
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| 80-89 yrs |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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