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Identification of Viruses Associated With Diseases of Unknown Cause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359268
Recruitment Status : Terminated (Slow/insufficient accrual)
First Posted : August 2, 2006
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description
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Brief Summary:

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.


Condition or disease
Viral Diseases

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
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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Identification of Novel Viruses
Actual Study Start Date : May 8, 2001
Actual Primary Completion Date : March 23, 2020
Actual Study Completion Date : March 23, 2020
Groups and Cohorts
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Group/Cohort
1
Any patient with a condition or disease whose etiology is unknown.


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a condition or disease whose etiology is unknown.
Criteria
  • INCLUSION CRITERIA:

Any patient with a condition or disease whose etiology is unknown.

Adequate venous access.

EXCLUSION CRITERIA:

None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359268


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Jeffrey I Cohen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Additional Information:

Publications:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00359268    
Other Study ID Numbers: 010161
01-I-0161
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Polymerase Chain Reaction
Random Priming
Nucleic Acid
Viral Genome
Additional relevant MeSH terms:
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Virus Diseases