Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004761
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Establishment of the National Epidermolysis Bullosa Registry
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
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:
OBJECTIVES I Develop a large roster of well-characterized patients with various forms of inherited and acquired epidermolysis bullosa EB
II Generate a large data bank of clinical historical and genetic information concerning these patients
III Accumulate donated tissue specimens including selected cells and DNA from selected patient subsets for the establishment of permanent tissue cell banks
IV Promote and facilitate research in EB
II Generate a large data bank of clinical historical and genetic information concerning these patients
III Accumulate donated tissue specimens including selected cells and DNA from selected patient subsets for the establishment of permanent tissue cell banks
IV Promote and facilitate research in EB
Detailed Description:
PROTOCOL OUTLINE Patients are enrolled by mail or clinic visit at 1 of 4 clinical centers Clinical epidemiological and laboratory data are collected
Medical and family histories are obtained in a detailed interview in person by phone or by mail Diagnostic studies to confirm the type of epidermolysis bullosa are performed as indicated A pedigree chart is completed on the first affected family member entered
Selected patients are followed at least biannually A study duration of approximately 10 years is anticipated
Medical and family histories are obtained in a detailed interview in person by phone or by mail Diagnostic studies to confirm the type of epidermolysis bullosa are performed as indicated A pedigree chart is completed on the first affected family member entered
Selected patients are followed at least biannually A study duration of approximately 10 years is anticipated
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RU-0170195 | None | None | None |