Viral Diseases Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03336086 -
Effect of Weight Reduction on Immunity
|
Phase 3 |