Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359268
Status:
TERMINATED
Last Update Posted:
2020-03-26
First Post:
2006-08-01
Brief Title:
Identification of Viruses Associated With Diseases of Unknown Cause
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Identification of Novel Viruses
Status:
TERMINATED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slowinsufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3-12 tablespoons for adults and 5 ml about 12 tablespoon per kilogram 22 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
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 3-12 tablespoons for adults and 5 ml about 12 tablespoon per kilogram 22 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-I-0161 | None | None | None |