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Trial record 8 of 85 for:    Open Studies | "Scleroderma, Systemic"

Scleroderma Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00074568
First received: December 16, 2003
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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).


Condition
Systemic Sclerosis
Scleroderma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Scleroderma Family Registry and DNA Repository

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Establish National registry of Scleroderma as resource for scleroderma scientific community [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, Plasma, DNA


Estimated Enrollment: 5000
Study Start Date: September 2000
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

Scleroderma refers to a group of diseases that involve the abnormal growth of connective tissue, which supports the skin and internal organs. Scleroderma can affect the skin, making it hard and tight; it can also damage the blood vessels and internal organs such as the heart, lungs, and kidneys. Estimates for the number of people in the United States with the systemic (body-wide) form of scleroderma range from 40,000 to 165,000. The number of people with all scleroderma-related disorders is between 250,000 and 992,500.

Researchers believe that several factors interact to produce scleroderma, including abnormal immune activity, potential environmental triggers, and genetic makeup. Scleroderma is not passed on from parents to child, but certain genes may make a person more likely to develop the disease. The goals of this project are to identify the genes that influence disease susceptibility and expression in systemic scleroderma and to establish a repository of DNA, plasma, and serum samples from single case scleroderma families, multicase families, and healthy unrelated volunteers for the use of researchers interested in studying this disease.

Participants in the Registry will have a phone interview regarding disease characteristics and family history. Participants will be sent a blood kit to get a blood sample drawn locally for shipment to the Registry lab. Blood samples will be made available (anonymously) for studies by researchers around the country. In some cases, participants will be asked to sign a release of medical information so that medical records can be obtained to verify the diagnosis.

As of May 2009, this study is no longer enrolling family members.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria

  • Diagnosis of systemic sclerosis or family members of patients with systemic sclerosis

Or

  • Healthy volunteer with no autoimmune disease and without a first-degree relative with a systemic autoimmune disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074568

Contacts
Contact: Jason Anderson 713-500-7196

Locations
United States, Texas
University of Texas - Houston Medical School Recruiting
Houston, Texas, United States, 77030
Contact: Jason Anderson    713-500-7196      
Principal Investigator: Maureen D. Mayes, MD, MPH         
Sub-Investigator: Frank C. Arnett, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Maureen D. Mayes, MD, MPH The University of Texas Health Science Center, Houston
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00074568     History of Changes
Other Study ID Numbers: NIAMS-108, N01AR02251-000, NO1-AR-0-2251
Study First Received: December 16, 2003
Last Updated: April 8, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Genetic Study
Transmission Dysequilibrium Testing
Genome Wide Scan
Family Study

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

ClinicalTrials.gov processed this record on November 25, 2014