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The exploring men's prostate cancer genetic risk perceptions and willingness to give a biospecimen for genetic risk testing study aims to assess prostate cancer genetic risk and susceptibility beliefs among unaffected men of diverse races/ethnicities who are considering undergoing prostate cancer screening and their willingness of men to provide a biospecimen (saliva sample) and test the samples for prostate cancer aggressiveness and determine risk category based on SNP genetic profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate Cancer Risk Group | Participants will be asked to provide saliva samples and complete a questionnaire about their Prostate Cancer Genetic Risk beliefs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Participants will be asked to complete a questionnaire on demographics, risk beliefs and perception and prostate cancer screening behaviors, intentions and awareness of informed decision making. |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate Cancer Genetic Risk and Susceptibility Beliefs | Prostate Cancer Genetic Risk and Susceptibility beliefs will be summarized based on single items on the Prostate Cancer Risk Perception Questionnaire. | Up to 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Polygenic Risk Score (PRS) of Saliva Samples | Polygenic Risk Score (PRS) of Saliva Samples will be based on genetic profiles from Single Nucleotide Polymorphisms (SNPs). Identified as prostate cancer susceptibility loci, genetic risk of developing prostate cancer will be categorized into 5 groups: Very Low Risk (< 10%), Low Risk (10-25%) Moderate Risk (25-75%), High Risk (75-90%) or Very High Risk (>90%). |
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Inclusion Criteria:
Exclusion Criteria:
This Study is evaluating Prostate Cancer risk
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Racially and ethnically diverse Adult Men with no personal Prostate Cancer history/diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Jong Park, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Participants will be asked to provide a saliva sample. Each enrolled participant will be provided the Oragene saliva collection kit (opt in) with collection, storage and mailing instructions per established protocols DNA extraction and genotyping assay will be done in Dr. Park's (PI) laboratory and Moffitt Cancer Center's Molecular Genomic Core facility, respectively
| Saliva Sample | Other | Participants will be asked to provide a saliva sample for genetic risk testing to generate a SNP risk profile using a saliva sample collection kit with collection, storage and mailing instructions. We will assess the proportion of consented men who will provide a saliva sample. |
|
| Up to 6 Months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |