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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02851875
Other study ID # Pro00067280
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 2016
Est. completion date May 7, 2018

Study information

Verified date September 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 42
Est. completion date May 7, 2018
Est. primary completion date May 7, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Registry


Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in disease activity as measured by Rodnan Skin Score The Rodnan skin score is a discrete measure of skin thickness that can change through time and in response to medication. Change from baseline at 10 years
Primary Change in disease activity as measured by patient reported Scleroderma Health Associated Questionnaire (SHAQ) The SHAQ is a measure of health and disability that produces a discrete value that can change through time and in response to medication. Change from baseline at 10 years
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