Identification of Viruses Associated With Diseases of Unknown Cause

Viral Diseases Clinical Trial

Official title:

Identification of Novel Viruses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00359268
• Other study ID #: 010161
• Secondary ID: 01-I-0161
• Status: Terminated
• Start date: May 8, 2001
• Est. completion date: March 23, 2020

Study information

• Verified date: March 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• INCLUSION CRITERIA:

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

Adequate venous access.

EXCLUSION CRITERIA:

None

Related Conditions & MeSH terms

• Viral Diseases
• Virus Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chang Y, Cesarman E, Pessin MS, Lee F, Culpepper J, Knowles DM, Moore PS. Identification of herpesvirus-like DNA sequences in AIDS-associated Kaposi's sarcoma. Science. 1994 Dec 16;266(5192):1865-9. — View Citation

Choo QL, Kuo G, Weiner AJ, Overby LR, Bradley DW, Houghton M. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science. 1989 Apr 21;244(4902):359-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page