Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395278
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2006-10-31
Brief Title:
Development of Serologic Assays for Human Herpes Virus-8
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Development of Serologic Assays for Human Herpes Virus-8
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dr Burbelo and colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of pathogens using recombinant proteins We would like to apply this technique to develop an assay for detecting antibodies to HHV-8 KSHV the etiologic agents of Kaposis sarcoma an AIDS-defining condition We initially plan to examine samples from patients with Kaposis sarcoma since all those patients are almost certainly infected with HHV-8 We are thus using samples from patients with previously diagnosed Kaposis sarcoma The samples in question are stored at the NCI FCRF repository operated by SAIC Frederick or in Rockville MD
Detailed Description:
Our colleagues have developed a technique for rapidly and quantitatively detecting antibody responses in sera to a variety of antigens using recombinant proteins We would like to apply this technique to develop an assay for detecting antibodies to HHV- 8 KSHV the etiologic agent of Kaposi s sarcoma an AIDS-defining condition In addition we would like to potentially measure antibody responses to HIV other infectious agents and human antigens to see if antibodies or high antibody titers to these antigens are associated with Kaposi s sarcoma or HIV infection We initially plan to examine samples from patients with Kaposi s sarcoma since all those patients are almost certainly infected with HHV-8 We would subsequently plan to examine samples from HIV positive and HIV negative patients without known Kaposi s sarcoma We are thus requesting permission to use samples from patients with and without previously diagnosed Kaposis Sarcoma In addition to antibody testing we would also like to examine these samples for evidence of infection with other infectious agents such as newly identified or unknown viruses using techniques such as PCR or deep
sequencing
sequencing
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 |
|---|---|---|---|
| 07-CC-N018 | None | None | None |