Identification of Viruses Associated With Diseases of Unknown Cause
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|ClinicalTrials.gov Identifier: NCT00359268|
Recruitment Status : Enrolling by invitation
First Posted : August 2, 2006
Last Update Posted : March 29, 2018
|First Submitted Date||August 1, 2006|
|First Posted Date||August 2, 2006|
|Last Update Posted Date||March 29, 2018|
|Study Start Date||April 27, 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00359268 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Identification of Viruses Associated With Diseases of Unknown Cause|
|Official Title||Identification of Novel Viruses|
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.
|Detailed Description||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.|
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status||Enrolling by invitation|
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Any patient with a condition or disease whose etiology is unknown.
Adequate venous access.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||010161
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )|
|Study Sponsor||National Institute of Allergy and Infectious Diseases (NIAID)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 11, 2017|