Currently Recruiting
National Registry for Childhood Onset Scleroderma (NRCOS)
Study sponsor:
Scleroderma Foundation
Coordinating center:
University of Pittsburgh School of Medicine, Department of
Rheumatology and Clinical Immunology
Principal Investigator:
Thomas A. Medsger, Jr., MD
412-383-8765.
Registry Coordinator:
Jennifer Jablon
412-383-8674, or jablonj@msx.dept-med.pitt.edu.
Please refer eligible patients to: 1-800-603-8960.
Other centers:
Recruiting from pediatric and adult rheumatologists and
dermatologists.
Design:
The objectives of this project are: (1) to examine the serum
antinuclear antibody (ANA) profiles in patients with childhood onset
scleroderma (SSc); (2) to determine the associations of these
autoantibodies with clinical and laboratory features of disease;
and, (3) to establish a large registry of patients with childhood
onset scleroderma to stimulate future research on this group of
disorders.
Subjects will be requested to provide a single blood sample, and
complete a yearly three page HAQ. Subjects' attending physicians
will complete a yearly one page follow-up form. No visit to the
University of Pittsburgh is required. All aspects of the study can
be completed through the mail.
Inclusion criteria:
Registry entry criteria include a physician-confirmed diagnosis of
one of the following: (1) systemic sclerosis (limited cutaneous or
diffuse cutaneous involvement alone or in overlap with another
connective tissue disease); (2) Raynaud's disease with either a
positive serum antinuclear antibody (ANA) test result or abnormal
nailfold capillaries; and, (3) localized scleroderma - including
plaque, generalized and deep (subcutaneous) morphea, linear
(includes "en coupe de sabre"), and eosinophilic fasciitis.
Exclusion criteria:
Subjects will be excluded if: (1) they do not have a
physician-confirmed diagnosis as explained in inclusion criteria;
(2) they are over the age of 30; (3) their disease onset was after
age 16; or, (4) they do not complete the informed consent
documentation or are unwilling to submit a blood sample.
Primary outcome measure:
This is not a clinical trial.
Recruitment period:
Ongoing
Completion:
Indefinite
Date of expected analysis:
After 200 subjects have been enrolled, ANA testing and data analysis
will begin.