Establishment of the National Epidermolysis Bullosa Registry - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 1986

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004761 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Establishment of the National Epidermolysis Bullosa Registry

Official Title ^ICMJE

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History, Longitudinal

Condition ^ICMJE

Epidermolysis Bullosa

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

- Clinical diagnosis of epidermolysis bullosa

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004761

Responsible Party

Study ID Numbers ^ICMJE

199/11706, RU-0170195

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Rockefeller University

Investigators ^ICMJE

Study Chair:

James G. Krueger

Rockefeller University

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

July 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP