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临床试验/NCT00359268
NCT00359268终止不适用

Identification of Novel Viruses

National Institute of Allergy and Infectious Diseases (NIAID)1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2001年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
59
试验地点
1
主要终点
The purpose of this protocol is to obtain blood, body fluids, skin or mucosal biopsies, or discarded pathologic specimens from patients with diseases or syndromes of unknown etiology.

研究概览

简要总结

This study will try to identify new or known viruses responsible for diseases or conditions of unknown cause. Viruses are an important cause of illness. They have been identified as causes of several cancers, including certain liver cancers and cervical cancer. Several diseases, such as Kawasaki s disease, aplastic anemia, aphthous ulcers, and certain fevers of unknown origin in immune suppressed patients are thought possibly to be due to viruses, but their cause has not yet been determined. This study will use very sensitive molecular techniques to try to identify new or known viruses in patients with conditions of unknown causes. This study does not involve any treatment.

Any patient with a condition or disease whose cause is unknown may be eligible for this study. A referral from a local physician is required for patients who wish to enroll in this study.

Participants will have blood samples drawn up to four times during the study. The total amount of blood drawn in any 6-week period will not exceed 50 milliliters (about 3-1/2 tablespoons) for adults and 5 ml (about 1/2 tablespoon) per kilogram (2.2 pounds) for children. In addition, body fluids, such as joint or spinal fluid, or tissue samples, such as biopsy specimens, obtained previously for medical purposes, may be obtained for testing.

The patient s doctor will be informed of any positive findings from the samples. Identification of a virus does not necessarily mean that the virus is causing the patient s condition or disease. Additional tests from many patients with similar diseases or conditions are required before a virus can be definitively associated with a disease. Similarly, failure to find a virus does not necessarily mean that the patient is not infected with a virus that is causing the condition, as the tests used in this study are imperfect and will not detect certain forms of viruses that can cause disease.

详细描述

Viral infections are an important cause of morbidity and mortality in hospitalized patients. Viruses have also been identified as the probable cause of a number of malignancies including hepatocellular carcinoma and cervical carcinoma. The purpose of this study is to identify novel viruses (or known viruses) that are associated with diseases whose etiology is unknown. Blood samples, body fluids, or discarded tissues (e.g. previous biopsy or autopsy material) saliva swabs, nasopharyngeal swabs, skin biopsies, or mucosal biopsies will be obtained from patients with clinical syndromes or diseases whose etiology is unknown. Highly sensitive assays using the polymerase chain reaction will be performed to attempt to identify novel or known viruses that might be present in the blood, body fluids, or tissues. Knowledge gained from this study could provide important insights into the cause of diseases whose etiology is presently unknown.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The purpose of this protocol is to obtain blood, body fluids, skin or mucosal biopsies, or discarded pathologic specimens from patients with diseases or syndromes of unknown etiology.

时间窗: Ongoing

Experimental studies will be performed on blood, body fluids, or discarded tissue specimens. Better understanding of the diseases of unknown etiology, improved diagnostic tests, and possible new treatments for diseases.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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