跳至主要内容
临床试验/NCT03289130
NCT03289130已完成不适用

The North Carolina-Louisiana Prostate Cancer Project, Project 3 Ancillary Study

University of South Carolina0 个研究点目标入组 2,258 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,258
主要终点
High aggressive prostate cancer

研究概览

简要总结

The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in prostate cancer aggressiveness and survival through a comprehensive evaluation of social, individual, and tumor level influences on prostate cancer aggressiveness. Project 3 specifically aims to examine nutritional modulation of prostate cancer aggressiveness using dietary assessment and biomarker-based data on dietary factors.

详细描述

A total of 2,258 (1,130 African Americans and 1128 European Americans) men newly diagnosed with prostate cancer in North Carolina and Louisiana were enrolled into the study between 2004 and 2009. Participants signed informed consent and were interviewed by a trained nurse who collected information on demographics, occupation, family history, health status, health care, prostate cancer diagnosis and screening history, medication use, anthropometrics, lifestyle factors (e.g., physical activity, smoking), and diet and supplement use. Research subjects were asked to recall their diet in the year prior to prostate cancer diagnosis via a modified version of the National Cancer Institute Diet History Questionnaire. Vitamin and supplement use in the year prior to prostate cancer diagnosis was assessed via a validated questionnaire, and current use was assessed by bottle label inventory. Blood, urine, and adipose tissue samples were collected.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 79 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • first diagnosis of histologically confirmed adenocarcinoma of the prostate
  • 40-79 years old at diagnosis,
  • can complete the study interview in English,
  • do not live in an institution (nursing home),
  • are not cognitively impaired or in a severely debilitated physical state,
  • are not under the influence of alcohol, severely medicated, or apparently psychotic at the time of the interview.
  • must self-identify as at least part African American/Black or Caucasian American/White/European American.

排除标准

  • 未提供

结局指标

主要结局

High aggressive prostate cancer

时间窗: Baseline (cross-sectional study)

Gleason score\>=8, or PSA\>20ng/ml, or Gleason score\>7 and clinical stage T3-T4

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Steck

Associate Professor

University of South Carolina

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