Rheumatologic Biobank for Clinical and Basic Research: Isolation, Extraction and Storage of Protein, DNA and RNA Extracted From Tissues of Patients With Rheumatoid Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- collecting samples
研究概览
简要总结
Serum, synovial fluid and skin biopsies from patients will be collected to the biobank with rheumatoid diseases. These samples will later be used for clinical and basic research, following approval of each specific study by the IRB. The investigators intend to extract protein, DNA and RNA from each sample.
详细描述
- PURPOSE Rheumatic diseases, being part of the auto-immune diseases, are rare inflammatory diseases which usually occur from an unknown reason. Various factors alone or in combination can trigger the disease, including pathogens, medications and stress, but the most prominent factor is the genetic background. These diseases are chronic, characterized by periods of flares and regression, and patients are often treated by various drugs. In routine check-up visits in the rheumatology clinic, patients are giving blood regularly in order to monitor the levels of cytokines and antibodies. However, the factors being assessed in the routine lab are limited, and the investigators believe there are much more proteins that can be studied in our research lab. Genomic studies of DNA and RNA isolated from blood of rheumatic patients are rarely being performed, and if they are - only at diagnosis. Combining both protein and genetic profiles of patients at diagnosis and follow up can be extremely useful both for basic and clinical research in helping us to understand the tendency to develop a disease, as well as disease progression and response to therapy. A rheumatoid bio-bank is the basis of establishing many studies leading us a step forward towards personalized medicine.
- DNA/ RNA resource DNA and RNA will be isolated from blood, synovial fluid or from skin tissue biopsies, related to the rheumatologic disease, derived from patients and normal donors who consent to participate in the rheumatologic Bio-Bank program. The DNA/RNA will be extracted, measured and stored in the bio-bank freezers. Blood samples will be drawn by a physician or accredited nurse, synovial fluid samples and skin biopsies will be collected by physicians only.
- Patient recruitment: Obtaining Informed Consent
General Principle:
Tissues will only be taken from adult patients who gave consent by means of a signed informed consent form.
All patients above the age of 18, referred to the Rheumatology clinic or Internal Medicine E Department at the Meir Medical Center, for investigation or treatment of suspected rheumatic disease, will be candidates to participate in the repository. Patients at their primary diagnosis or follow up will be eligible for this study. Recruitment of patients and obtaining informed consent will be done by physicians only. No tissue for DNA/RNA isolation will be taken from patients prior to obtaining their written consent or from those who do not consent.
Number of sample in the bio-bank: 500 for each year 4. Identifying Patients Entitled for Sample Collection 4.1 - General responsibility: The bio bank manager, Dr. Yair Levy, will hold responsibility for appropriate storage and privacy protection of samples, and will be in charge of the bio bank staff.
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 120 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •above 18 years of age
- •willing to sign informed consent
- •have a rheumatoid condition
排除标准
- 未提供
结局指标
主要结局
collecting samples
时间窗: 20 years
IgG4-related disease patients
次要结局
未报告次要终点
