NCT04499534进行中（未招募）不适用
Influenza Vaccine Study in BRCA1 or BRCA2 Carriers
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To evaluate immune function in female BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination
研究概览
简要总结
To evaluate immune function in BRCA1/2 mutation carriers without cancer, specifically to determine whether immune function in healthy individuals with germline loss of function BRCA1/2 mutations, impacts overall immune health and fitness.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •Over age 25
- •BRCA1 or BRCA2 pathogenic or likely pathogenic mutation
- •No personal cancer history apart from non melanoma skin cancer, localized thyroid cancer, in situ cancers of any type
- •Participants must sign the informed consent form
排除标准
- •Are allergic to influenza vaccination
- •Have received influenza vaccination within the past 6 months
- •Require prednisone, methotrexate, or other immunosuppressing medications
- •Have HIV infection
- •Have a history of solid organ tumor or bone marrow transplant
- •Require combination immunotherapy;
- •Are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study
结局指标
主要结局
To evaluate immune function in female BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination
时间窗: 2 years
Analysis of the primary objective will depend on determination of the strain-specific neutralizing antibody titer change from day 0 to the last study visit, performed as the standard assay as described by the World Health Organization (WHO).
次要结局
- Exploratory analysis - transcriptional evaluation(2 years)
- Exploratory analysis- phenotypic evaluation of B cell(2 years)
研究者
研究点 (2)
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