Collection of Blood, Bone Marrow and Tissue Samples for the Investigation of the Human Immune Response, Lymphoma Biology and HTLV-1 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 902
- 试验地点
- 1
- 主要终点
- Create Biobank
研究概览
简要总结
This protocol is being submitted to consolidate, update, and expand two previously approved protocols (77-C-0066 and 82-C-0044) into a single protocol. The purpose of this study is to examine the factors involved in the regulation of the immune system of healthy individuals and to define the abnormalities in this regulation that underlies the immunological disorders of patients with a variety of immunodeficiency and malignant disorders. The studies will include the ex vivo phenotypic and functional analysis of the network of cells involved in humoral and cellular immune responses, and in vivo testing for the capacity to make delayed-type hypersensitivity and humoral responses following immunization with a variety of antigens. Individuals to be studied will include patients with a variety of malignancies and patients with primary and secondary immunodeficiency disorders. Selected family members or family members known to be genetic carriers of certain immunodeficiency diseases as well as normal, unrelated individuals will also be studied. A small number of procedures will be used including analysis of blood obtained by phlebotomy, apheresis, skin testing and recall antigens and immunization to assess humoral immunity....
详细描述
Background:
- The evaluation of the cells of the immune system and HTLV-1 infection has been a central focus of the Metabolism Branch for the past 30 years.
- Blood obtained by apheresis or blood drawing, skin biopsies and other tissues will be evaluated for abnormalities related to immunity, HTLV-1 infection and the immune system.
- Advances in the characterization of acquired genetic changes in tumor samples has
led to insights for the development of targeted therapy of malignancy
Objectives:
- To characterize the molecular biology and immunological features as well as the clinical course of individuals with suspected or known disorders of the immune system or cancer
- To define the nature of the immunological, genetic and epigenetic abnormalities in the cells of patients with immunodeficiency diseases associated with infections and/or a high incidence of malignancy and in patients with cancer.
- To obtain whole blood, plasma and leukocytes, as well as skin, lymph node and bone marrow biopsies on patients with immunodeficiency or cancer to investigate the immune system.
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnant women will not be eligible for any aspect of this protocol.
- •Exclusion Criteria for Apheresis Alone:
- •Any diagnosed medical condition which may be worsened by the apheresis procedure. Specifically the participant should not have any of the following:
- •Congestive Heart Failure
- •History of angina
- •Severe hypotension (at the discretion of the participant's physician, the apheresis staff and the attending physician from the Department of Transfusion Medicine (DTM) per DTM Standard Operating Policies.)
- •Poorly controlled hypertension (average baseline blood pressure greater than 160/90)
- •History of a coagulation protein disorder.
- •Pediatric patients (less than 18 years) will not undergo apheresis.
结局指标
主要结局
Create Biobank
时间窗: Ongoing
No statistical endpoints are identified for this study; the purpose of the study is to acquire information regarding various immunodeficiency syndromes, HTLV-1 infection and malignancies. The data collected will not be combined for a summary report of the entire study; however, reports for specific disease entities may be published.
次要结局
未报告次要终点