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临床试验 NCT05869747 (FCRP) 针对暴露，心肺目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Firefighter Collaborative Research Project (FCRP)
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临床试验NCT05869747 (FCRP)是一项针对暴露，心肺的干预性研究试验，目前试验状态为进行中但不再招募。试验始于2023年6月22日，计划招募1,500名患者。该研究由University of Arizona主导，预计于2025年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年6月4日。
简要概括
The goal of this research is to test interventions to reduce firefighter cardiovascular, cognitive, and overall disease risks, including but not limited to risks associated with Per- and Polyfluorinated Substances (PFAS) exposure. Approximately 1,500 - 2,000 firefighters will be enrolled in the Fire Fighter Cancer Cohort Study (FFCCS). Among these individuals, those that express interest will then be screened for eligibility for the Firefighter Collaborative Research Project (FCRP) using information they provided for the Fire Fighter Cancer Cohort Study. Firefighters enrolled in the study will provide an initial blood sample and urine sample. The blood sample will be analyzed to determine the participant's PFAS levels. Based upon serum PFAS levels and responses from the screening survey, eligible participants will be randomly assigned into one of the following interventions: 1. Blood Donation, or Plasma Donation or Blood/Plasma Control Group; 2. Zone 2 Training or Zone 2 Control; 3. Intermittent Fasting or Intermittent Fasting Control. Individuals participating in the blood donation, plasma donation or blood/plasma control group would donate blood every 12 weeks, plasma every 6 weeks, or not donate blood or plasma. Participants in this intervention arm would continue this for a 12-month period. Individuals in the zone 2 training, zone 2 training control, intermittent fasting or intermittent fasting control group would participate in their intervention or control for a 4-month period. After 4 to 12 months participating in an intervention or control group, participants will be asked to provide a final urine sample and blood draw to determine if and to what degree their PFAS levels or other cardiovascular disease and other health risks have changed.
官方标题
Firefighter Collaborative Research Project
疾病
暴露心肺出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- FCRP
NCT编号
实际开始日期
2023-06-22
最近更新发布
2025-06-04
预计完成日期
2025-12-31
计划入组人数
1,500
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中但不再招募
关键词
Firefighters
主要目的
其他
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Blood Donation | 献血 Participants asked to donate whole blood at a donation facility from a list provided by the study. 调查 Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
阳性对照Plasma Donation | Plasma Donation Participants asked to donate plasma at a donation facility from a list provided by the study. 调查 Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
安慰剂对照Blood/Plasma Control | 调查 Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
阳性对照Zone 2 Training | Zone 2 Training Participants asked to work out in their custom Zone 2 heart range 4 times a week for 45 to 60 minutes. 调查 Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
阳性对照Intermittent Fasting | 间歇性禁食 Participants asked to engage in an intermittent fasting routine of a 16 hour fast followed by an 8 hour eating period at least 4 times a week. 调查 Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
安慰剂对照Zone 2 Control | 调查 Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
安慰剂对照Intermittent Fasting Control | 调查 Participants were asked to complete surveys throughout the study to monitor intervention progress and to collect baseline and end-of-study data. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in concentration of PFAS levels in serum | PFAS levels are per- and polyfluoroalkyl substance levels measured from a biological sample | 12 months |
Change in epigenetic age | Epigenetic age is a mathematically derived age estimators that are based on combinations of methylation values that change with age at specific CpGs in the genome. | 4 months |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- Active firefighter (including emergency medical responder and all firefighter subgroups) with either a volunteer or career status
- Individual plans to remain in active service with their current agency for the next 2 years (not planning to retire or resign)
- 18 years of age and older
- Fluently speak and write in English
- All sexes, races, and ethnicities
- Enrolled in the Fire Fighter Cancer Cohort Study (FFCCS) prior to enrolling in the Firefighter Collaborative Research Project (FCRP)
- Complete a signed and dated informed consent document that indicates the participant has been informed of all aspects of the study prior to enrollment
- Agree to avoid participating in FCRP intervention activities outside of their assigned intervention group for the duration of the study
- Able to comply with scheduled visits, laboratory tests and other study procedures
- BMI of 17.5 kg/m2 or greater and be greater than 115 pounds
- Must also be eligible to donate blood and blood-based products if randomized into the blood or plasmapheresis intervention groups
- Not able to fluently speak or write in English
- Less than 18 years of age
- Currently a tobacco smoker or vaping (e.g. >2 cigarettes or cigars, or incidents of vaping in the past month)
- Those with planned travel or extended leave (e.g. >6 weeks) that would prevent their ability to participate in other interventions
- Those who are pregnant, breastfeeding, or have given birth within the past year
- Those with a history or diagnosis of any significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urological disorders, severe injury or cancer that, in the opinion of the investigator, would potentially put the candidate at risk.
Exclusion criteria from study for those outside of Arizona:
• Those with PFOS levels <5 ng/ml
Exclusion criteria from blood or plasma donation intervention:
- Those with any medical contraindication (medical condition or medication) to blood donation
- Those that donated blood or plasma in the past three months
- Those knowing they have a condition indicative of levels of hemoglobin, hematocrit, red blood cells, or iron below the lower limit of normal levels
Exclusion criteria from the intermittent fasting intervention:
- Those with a history or diagnosis of diabetes, hypoglycemia thyroid disease, and/or an eating disorder
- Those who recently participated in intermittent fasting or Time Restricted Eating
- Those that recently used antidiabetic medication such as Semaglutide (sold as Ozempic, Wegovy, and Rybelsus) or Tirzepatide (sold as Mounjaro) for the treatment of type 2 diabetes or for weight loss will also be excluded from this group.
- Use of drugs that might affect intermittent fasting or eating behaviors
- Those outside of the state of Arizona
Exclusion from the zone-2 physical activity intervention:
- Currently participating in zone 2 physical activity training
- Currently participating in more than 120 minutes per week of aerobic, cardiovascular training (e.g. jogging, cycling, walking, swimming, HIIT) at >60% of their max heart rate.
- Those outside of the state of Arizona or in cities in Arizona where access to CPET testing is not possible
University of Arizona亚利桑那州立大学没有联系数据。
7 位于 1 个国家/地区的研究中心
Arizona
Gilbert Fire & Rescue Department, Gilbert, Arizona, 85295, United States
Green Valley Fire, Green Valley, Arizona, 85622, United States
Tucson Fire Department Headquarters, Tucson, Arizona, 85701, United States
Tucson Fire Department Station 9, Tucson, Arizona, 85711, United States
University of Arizona, Tucson, Arizona, 85719, United States
Northwest Fire District, Tucson, Arizona, 85743, United States
Drexel Heights Fire, Tucson, Arizona, 85746, United States