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Trial record 9 of 14 for:    RDEB | California, United States

Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01019148
Recruitment Status : Recruiting
First Posted : November 25, 2009
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University

Tracking Information
First Submitted Date November 20, 2009
First Posted Date November 25, 2009
Last Update Posted Date July 19, 2018
Study Start Date November 2009
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2016)
Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa [ Time Frame: 4 years ]
Identification of subjects with Recessive Dystrophic Epidermolysis Bullosa for future studies
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa
Official Title Characteristics of Patients With Recessive Dystrophic Epidermolysis Bullosa
Brief Summary 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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Skin biopsies, serum
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with RDEB by a local dermatologist who are medically stable enough to travel to Stanford University Medical Center. Patients should also be at least 7 years of age.
Condition Epidermolysis Bullosa Dystrophica
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 17, 2018)
70
Original Estimated Enrollment
 (submitted: November 20, 2009)
20
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Irene Bailey-Healy (650) 721-7149 baileyhi@stanford.edu
Contact: Melissa Barriga mbarriga@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01019148
Other Study ID Numbers SU-11182009-4402
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jean Yuh Tang, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Jean Tang, MD, PhD Stanford University
PRS Account Stanford University
Verification Date July 2018