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临床试验/NCT02353221
NCT02353221已完成不适用

California Pacific Medical Center Early Undifferentiated Arthritis Registry

California Pacific Medical Center Research Institute1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Diagnosis of inflammatory arthritis

研究概览

简要总结

The CPMC early arthritis registry will recruit participants from a population of new patients undergoing evaluation at the office of participating physicians. Patients enrolled in the registry will undergo longitudinal observation and sampling. The investigators will collect questionnaire data and create a biological sample repository. The information obtained will be use to generate hypotheses aimed at explaining how environmental and genetic factors are interrelated to influence UA disease outcomes. Analysis will be performed on the patient's data and biological samples in order to; A. Assess the epidemiological and clinical characteristics of patients with early arthritis in the referral pool at CPMC.

B. Analyze the phenotype and genotype of peripheral blood mononuclear cells (PBMC) from individual patients based on their chemokine/cytokine secretion, cell adhesion molecule expression, gene expression, DNA methylation and non coding RNA profiles.

C. Generate hypothesis aimed to identify clinical criteria and novel biomarkers to be used in the diagnosis, prognosis, and therapeutic decisions for patients with early UA

详细描述

Experimental Design/Procedural Methods:

Study Objectives:

The CPMC early arthritis registry will recruit participants from a population of new patients undergoing evaluation at the office of participating physicians. Patients enrolled in the registry will undergo longitudinal observation and sampling. The investigators will collect questionnaire data and create a biological sample repository. The information obtained will be use to generate hypotheses aimed at explaining how environmental and genetic factors are interrelated to influence UA disease outcomes. Analysis will be performed on the patient's data and biological samples in order to; A. Assess the epidemiological and clinical characteristics of patients with early arthritis in the referral pool at CPMC.

B. Analyze the phenotype and genotype of peripheral blood mononuclear cells (PBMC) from individual patients based on their chemokine/cytokine secretion, cell adhesion molecule expression, gene expression, DNA methylation and non coding RNA profiles.

C. Generate hypothesis aimed to identify clinical criteria and novel biomarkers to be used in the diagnosis, prognosis, and therapeutic decisions for patients with early UA.

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 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Entry criteria include being at least 18 years old at screening visit
  • Being able to understand the information given to them and to give written informed consent
  • Willingness to comply with the requirements of the data collection
  • Absence of a diagnose of autoimmune disease or inflammatory arthritis
  • Absence of a previous treatment with any disease modifying anti-rheumatic drug (DMARD)

排除标准

  • We will exclude patients that are pregnant or intend to become pregnant during the time of follow up.

结局指标

主要结局

Diagnosis of inflammatory arthritis

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro Ruiz

Rheumatologist

California Pacific Medical Center Research Institute

研究点 (1)

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