The Role of Genetic Polymorphisms in Innate Immune Response Genes in Susceptibility to Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Risk for developing infection or lymphoma due to allelic variation in genes of immune system that specialize in pathogen recognition compared to absence of allelic variation.
研究概览
简要总结
The purpose of this study is to better understand genetic susceptibility to infections and the interactions of specific genetic polymorphisms of innate immune receptors with microbial and fungal organisms.
The goals of this study are:
- Find out if some people are more likely to get severe infections, than others. To do this we will compare patients with leukemia who develop severe infections to patients who do not develop infections.
- Find out if some people are more likely to develop lymphoma than others. To do this we will compare patients with lymphoma to people without lymphoma who are of the same sex and similar age and ethnic background to the patients with lymphoma.
详细描述
A small number of patients will develop severe infection after chemotherapy or after allogeneic bone marrow transplantation. The ability of patients with leukemia or bone marrow transplantation to fight infections is decreased. One reason is that chemotherapy transiently destroys the type of white blood cells called neutrophils. Neutrophils are the first line of defense of our body against infections. Bone marrow transplant patients may be receiving edications to prevent graft versus host disease. Such medications may decrease the ability of the body to fight infections.
People respond to infections in different ways. Some may be born with genes that make them more likely to get certain types of infections. Specific genes may affect the response to different microbes (pathogens). We want to find out which genes have normal changes in them and lead to different responses to infections. We also want to find out how the ability to fight infections is related to the way these genes work.
Responses to infection are controlled by our immune system. Changes in genes of the immune system that may alter control of infection may make people more susceptible to some types of lymphoma The goals of this study are:
- Find out if some people are more likely to get severe infections, than others. To do this we will compare patients with leukemia who develop severe infections to patients who do not develop infections.
- Find out if some people are more likely to develop lymphoma than others. To do this we will compare patients with lymphoma to people without lymphoma who are of the same sex and similar age and ethnic background to the patients with lymphoma.
The purpose of this study is to better understand genetic susceptibility to infections and the interactions of specific genetic polymorphisms of innate immune receptors with microbial and fungal organisms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must either:
- •Have histologically confirmed acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), follicular or mantle cell lymphoma RA-EB, RAEB-T newly diagnosed at first or second remission AND are going to receive or have received myelosuppressive chemotherapy; OR
- •Will receive or have received allogeneic HSCT for hematologic malignancy.
- •Subject has signed informed consent before entering the study.
- •Participation of children: For subjects under the age of 18, we will obtain the subject's and their parents' approval to enroll them.
排除标准
- •Subject has been diagnosed with leukemia other than acute myeloid leukemia RA-EB or RAEB-T or acute lymphocytic.
- •Subject is not going to receive chemotherapy or has not received chemotherapy.
- •Subject will undergo/had undergone HSCT for disease other than hematologic malignancy.
结局指标
主要结局
Risk for developing infection or lymphoma due to allelic variation in genes of immune system that specialize in pathogen recognition compared to absence of allelic variation.
时间窗: 6 years
次要结局
- Risk for developing infectns due to somatic mutatns/polymorphisms in genes involved in signaling pathways downstream of receptors of immune recognitn.Characterize in vitro diff in functional responses to pathogens among genetic variants.(6 years)