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Duke Scleroderma Clinic Patient Registry

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. Identifier: NCT02851875
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : May 15, 2018
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about scleroderma. This information could be used in future research to increase the understanding of disease mechanisms, treatments, and outcomes. This research may also help develop new therapies, novel measures of disease assessment or identify previously unknown manifestations of the diseases. A prospectively followed cohort is an integral component of future translational and clinical research programs. A registry for scleroderma would allow for information to be gleaned about patients in "real-world situations" in an effort to improve the reality, generalizability and applicability of information gathered.

Condition or disease Intervention/treatment
Scleroderma Systemic Sclerosis Other: Registry

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:

  1. Clinical data obtained by clinicians and entered electronically into a secure database
  2. Laboratory, procedure, and imaging data obtained over the course of clinical care
  3. 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Duke Scleroderma Clinic Patient Registry
Study Start Date : April 2016
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Primary Outcome Measures :
  1. Change in disease activity as measured by Rodnan Skin Score [ Time Frame: Change from baseline at 10 years ]
    The Rodnan skin score is a discrete measure of skin thickness that can change through time and in response to medication.

  2. Change in disease activity as measured by patient reported Scleroderma Health Associated Questionnaire (SHAQ) [ Time Frame: Change from baseline at 10 years ]
    The SHAQ is a measure of health and disability that produces a discrete value that can change through time and in response to medication.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients 18 and older with a history of scleroderma or systemic sclerosis.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02851875

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Contact: Ankoor Shah, MD 919-681-1505
Contact: Edna Scarlett

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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Ankoor Shah, MD    919-681-1505   
Contact: Edna Scarlett   
Sponsors and Collaborators
Duke University
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Principal Investigator: Ankoor Shah, MD Duke University

Additional Information:

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Responsible Party: Duke University Identifier: NCT02851875     History of Changes
Other Study ID Numbers: Pro00067280
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases