Interaction Between Environment, Diet, Physical Activities, and Sexual Habits, in the Risk of Prostate Cancer. Validation of Biomarkers to Personalize Preventive Interventions (BIOCaPPE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,053
- 试验地点
- 4
- 主要终点
- Biomarkers and modifiable exposure environment
研究概览
简要总结
The risk of prostate cancer is associated with lifestyle habits, such as diet and physical activity. Indeed, results of numerous studies suggest links between obesity, diabetes, inflammation and androgen and estrogen metabolism in the pathogenesis of prostate cancer.
The goal of BIOCaPPE study (Biomarkers and Prostate Cancer/ Prevention and Environment) is to identify biomarkers of prostate cancer risk that are potentially modifiable by environmental exposures (e.g. diet and physical activity).
A selection of few of the most promising biological markers will be evaluated in a cohort of more than 2000 men at high-risk of prostate cancer.
Such biomarkers would provide a practical approach to identify men at high risk of prostate cancer who could benefit from interventions aiming at reducing their risk. The biomarkers would also be useful to monitor the efficacy of the interventions on patient's lifestyle.
详细描述
The main objective of the proposed research project is to assess the association between five candidate biological markers potentially modifiable by environmental exposures (diet and physical activity) and the two-year risk of prostate cancer in a newly recruited cohort of men at high-risk of prostate cancer showing no evidence of cancer.
Four hospitals in the province of Quebec (Canada) participate to the recruitment of 2,055 men at high-risk for prostate cancer, i.e. men who had a first negative prostate biopsy or whose Prostatic Specific Antigen (PSA) level is between 2.5 and 10 ng/mL without previous prostate biopsy.
The candidate biomarkers that will be tested are:
- The ratio of ω-3/ ω-6 fatty acid content of red blood cell membranes,
- Oxidized low density lipoprotein cholesterol
- Adiponectin
- Insulin growth factor-1
- The ratio of dihydrotestosterone glucuronide derivatives over estradiol
A biobank, composed of biological material (whole blood, plasma, serum, lymphocyte layer and excess tissue collected from prostate biopsy or prostate surgery) and clinical data is being created. Questionnaires are used to compile information on socio-demographic aspects, family and personal medical history, quality of life, lifestyle like food and sexual habits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Group 1: A first negative prostate biopsy within 6 months
- •Group 2: serum-PSA level between 2.5-10 ng/mL and no prior prostate biopsy
排除标准
- •Prostate cancer
- •Positive result for transurethral prostatic resection
结局指标
主要结局
Biomarkers and modifiable exposure environment
时间窗: An average of 2 years
Assess the association between five candidate biological markers potentially modifiable by environmental exposures, mainly diet and physical activity, with the two-year risk of prostate cancer in men at risk for prostate cancer as previously defined.
次要结局
- Study biobank(Through study completion, every year up to 2 years)