Duke Scleroderma Clinic Patient Registry

NCT02851875 | Terminated

• 1 other identifier: Pro00067280
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma; Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Registry OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 18 and older with a history of scleroderma or systemic sclerosis.

You may qualify if:

• Patients with a history of systemic sclerosis or Scleroderma as identified by the 2013 American College of Rheumatology classification criteria

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Interventions

Registries

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ankoor Shah, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: August 2, 2016
• Study Start: April 1, 2016
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: January 29, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)