Scleroderma Registry

NCT00074568 | Completed

• 3 other identifiers: NIAMS-108N01AR002251-000NO1-AR-0-2251
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Scleroderma is likely caused by a combination of factors, including an external trigger (infection or other exposure) and a genetic predisposition. The Scleroderma Registry will conduct genetic analyses for disease-related genes in patients with scleroderma and their family members (parents, brothers, and sisters).

Conditions

Systemic Sclerosis; Scleroderma

Keywords

Genetic Study; Transmission Dysequilibrium Testing; Genome Wide Scan; Family Study

Outcome Measures

Primary Outcomes (1)

• Establish National registry of Scleroderma as resource for scleroderma scientific community

  ongoing

Study Arms (2)

1

Patients with scleroderma and their family members (parents, brothers, and sisters)

2

Healthy volunteers with no autoimmune disease and without a first-degree relative with a systemic autoimmune disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Systemic Sclerosis or family member of patients with systemic sclerosis or Healthy volunteer with no autoimmune disease and without a first degree relative with a systemic autoimmune disease.

You may qualify if:

• Diagnosis of systemic sclerosis or family members of patients with systemic sclerosis
• Healthy volunteer with no autoimmune disease and without a first-degree relative with a systemic autoimmune disease

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Texas - Houston Medical School

Houston, Texas, 77030, United States

Location

Related Publications (3)

• Mayes MD, Giannini EH, Pachman LM, Buyon JP, Fleckman P. Connective tissue disease registries. Arthritis Rheum. 1997 Sep;40(9):1556-9. doi: 10.1002/art.1780400903. No abstract available.

  PMID: 9324008 BACKGROUND

• Mayes MD. The establishment and utility of a population-based registry to understand the epidemiology of systemic sclerosis. Curr Rheumatol Rep. 2000 Dec;2(6):512-6. doi: 10.1007/s11926-000-0029-3.

  PMID: 11123106 BACKGROUND

• Mayes MD. Scleroderma epidemiology. Rheum Dis Clin North Am. 2003 May;29(2):239-54. doi: 10.1016/s0889-857x(03)00022-x.

  PMID: 12841293 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, DNA

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

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

Study Officials

• Maureen D. Mayes, MD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2003
• First Posted: December 17, 2003
• Study Start: September 1, 2000
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Locations

US (1)