Epidermolysis BullosaNCT00004761
Establishment of the National Epidermolysis Bullosa Registry
An observational study of Epidermolysis Bullosa, run by National Center for Research Resources (NCRR).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Epidermolysis Bullosa
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1986to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Clinical diagnosis of epidermolysis bullosa
About this study
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.
Read the 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.
- Conditions
- Epidermolysis Bullosa
- Keywords
- dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease
- Medical subject headings
- Epidermolysis Bullosa, Skin Diseases, Genetic Diseases, Inborn, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startSep 1986
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Rockefeller University
- Investigators
- James G. Krueger, Study chair, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004761
- Sponsor's protocol ID
- 199/11706
- Other IDs
- RU-0170195
- Status last verified
- Jul 2004
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Lin AN, Carter DM: Epidermolysis Bullosa: Basic and Clinical Aspects. New York: Springer Verlag, 1992.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of the National Epidermolysis Bullosa Registry
- ClinicalTrials.gov ID
- NCT00004761
- Acronym / sponsor ID
- 199/11706
- Conditions
- Epidermolysis Bullosa
- Keywords
- dermatologic disorders, epidermolysis bullosa, genetic diseases and dysmorphic syndromes, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Rockefeller University
- Study start
- Sep 1986
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- BackgroundLin AN, Carter DM: Epidermolysis Bullosa: Basic and Clinical Aspects. New York: Springer Verlag, 1992.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James G. Krueger study chair
Rockefeller University
Questions about this trial
What is this clinical trial studying?
An observational study of Epidermolysis Bullosa, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.