Biobank for African American Prostate Cancer Research in Florida
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 592
- 试验地点
- 1
- 主要终点
- Number of Complete Patient Data Records Collected at Three Years
研究概览
简要总结
The purposes of this study are: a) to develop a statewide Biobank for prostate cancer among men of African Ancestry in Florida and; b) to examine whether smoking increases the aggressiveness of prostate cancer using several biological approaches.
Investigators plan to contact African American prostate cancer patients regarding participation. This project has 3 main components. Eligible patients may choose to participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.
详细描述
This project will create the first state-wide data and biospecimen bank for men of African ancestry with prostate cancer. The sampling strategy and size of the study population ensure that the cohorts is representative, enhancing validity of studies based on this resource. In addition, there are no data on the role of smoking in African American prostate cancer. The approach to share the resource with Florida prostate cancer researchers is innovative and possible because the four annual prostate cancer symposiums organized by Moffitt has unified many Florida prostate cancer researchers who are now well connected and actively collaborating, as evidenced by publications and funded projects among participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The initial recruitment of cases will be done with 3 mailings: the first to introduce the study to the participant from Florida Cancer Data System (FCDS) of the Florida Department of Health and ask them to complete the eligibility form and contact information update form; a second mailing to those who are determined to be eligible for the study to obtain the Informed Consent Form and the Baseline survey; and a third mailing to those who completed the survey to obtain a saliva sample and medical release form for tissue.
- •Histologically biopsy confirmed, primary prostate cancer, diagnosed between January 2013 and December 2015
- •African American or Black; Hispanic Black; Afro-Caribbean
- •Are at least 20 years old
- •Are a resident of Florida
- •Additional criteria may apply
排除标准
- •Does not meet Inclusion Criteria
结局指标
主要结局
Number of Complete Patient Data Records Collected at Three Years
时间窗: Up to 3 years
The study timeline is up to 3 years to collect detailed patients' data, outcome information and bio-specimens from men of African Ancestry with prostate cancer (n=6,000), diagnosed between January 2013 and December 2015.
次要结局
- Rate of Impact of Smoking in Prostate Cancer Aggressiveness - All Participants(Up to 3 years)
- Rate of Impact of Smoking in Prostate Cancer Aggressiveness - Current Smokers(Up to 3 years)
- Number of Participants with Genetic Markers for Smoking Aggressiveness(Up to 3 years)
- Number of Participants with Epigenetic Markers for Smoking Aggressiveness(Up to 3 years)