- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02851875
Duke Scleroderma Clinic Patient Registry
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Duke Scleroderma Registry (DSScR) will include 3 types of data collected at each standard of care office visit, generally every 3-6 months. The data will include:
- Clinical data obtained by clinicians and entered electronically into a secure database
- Laboratory, procedure, and imaging data obtained over the course of clinical care
- Photographs of clinically relevant physical findings.
Data that will be stored include historical data on patients' disease and concurrent medical conditions, physical exam findings, laboratory values, imaging and other diagnostic testing results, detailed list of medications and treatments, and quality of life questionnaire data. Historical information will include detailed medical, obstetric, surgical, procedural, social, and family history of disease comparable to information gathered at a typical initial visit. No protected health information will be collected or stored on family members. Data collected will be stored in a secure computer database as well as in a clinic note and will be used for patient care purposes. Protected health information (PHI) that will accompany subject data include name, medical record number, address, phone number, date of birth, dates of diagnoses, dates of procedures, and dates of clinic visits.
The database will be maintained indefinitely; there is no planned endpoint to the collection of the data and maintenance of the database as the investigators are planning a long term prospective evaluation of persons with these diseases.
Subjects will be serially approached/recruited from existing patients in the Duke Rheumatology Adult Clinic. The project will be introduced to each prospective subject by someone involved in their clinical care. A waiver of consent and Health Insurance Portability and Accountability Act (HIPAA) authorization has been filed for the Duke Scleroderma Registry. Persons who have been diagnosed with scleroderma will be identified through monitoring of outpatient clinic lists and the inpatient consult service.
Research records will be archived upon completion of the study. Subject initials and study number will be used to identify subjects in the research material and on research specimens. All electronic data is stored on the shared drive and secured through the following Duke Health Technology Services approved methods: access rights granted and terminated for authorized users only, secure laptops and workstations, individual identifier plus password protection, routine electronic back up, network restrictions.
During the initial screening process, no identifying information (e.g., name, address) will be kept. During the consent process, participants will be informed of data storage and confidentiality safeguards, which are practiced according to HIPAA regulations. Each participant will be assigned a unique identifier (ID) number. All data will be de-identified and coded with this number only.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with a history of systemic sclerosis or Scleroderma as identified by the 2013 American College of Rheumatology classification criteria
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in disease activity as measured by Rodnan Skin Score
Time Frame: Change from baseline at 10 years
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The Rodnan skin score is a discrete measure of skin thickness that can change through time and in response to medication.
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Change from baseline at 10 years
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Change in disease activity as measured by patient reported Scleroderma Health Associated Questionnaire (SHAQ)
Time Frame: Change from baseline at 10 years
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The SHAQ is a measure of health and disability that produces a discrete value that can change through time and in response to medication.
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Change from baseline at 10 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ankoor Shah, MD, Duke University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00067280
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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