Identification of Viruses Associated With Diseases of Unknown Cause

NCT00359268 | Terminated

• 2 other identifiers: 01016101-I-0161
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Diseases

Keywords

Polymerase Chain Reaction; Random Priming; Nucleic Acid; Viral Genome

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (1)

1

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a condition or disease whose etiology is unknown.

You may qualify if:

• Any patient with a condition or disease whose etiology is unknown.
• Adequate venous access.

You may not qualify if:

• None

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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. doi: 10.1126/science.2523562.

  PMID: 2523562 BACKGROUND

• 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. doi: 10.1126/science.7997879.

  PMID: 7997879 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Jeffrey I Cohen, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: May 8, 2001
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

US (1)