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Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

NCT ID: NCT01019148

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-10

Study Completion Date

2029-12-31

Brief Summary

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Recessive dystrophic epidermolysis bullosa (RDEB) is a disease caused by genetic mutations in the gene for type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening subjects with RDEB to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy and determine whether subjects could be candidates for treatment studies.

Detailed Description

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We will obtain a detailed medical history and will perform a skin examination and brief physical exam. Photographs may be taken. We will ask questions about the size and duration wounds.

LAB TESTS We will draw blood to determine overall health status to include Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV) testing. Genetic testing may also be performed.

BIOPSIES Biopsies may be collected to check for Collagen 7 and for antibodies to Collagen 7.

Based on the results obtained, it may be possible to identify patients who would qualify to participate in current or future clinical trials.

Conditions

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Epidermolysis Bullosa Dystrophica

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of RDEB by local dermatologist
* 7 years of age or older

Exclusion Criteria

-Medical instability limiting ability to travel to Stanford University Medical Center
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jean Yuh Tang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Irene Bailey-Healy

Role: CONTACT

[email protected]
(650) 721-7149

Facility Contacts

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Irene Bailey-Healy

Role: primary

[email protected]
650-721-7149

Other Identifiers

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SU-11182009-4402

Identifier Type: -

Identifier Source: org_study_id