Scleroderma Registry (Registry)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00074568 |
Recruitment Status : Unknown
Verified November 2019 by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
Recruitment status was: Recruiting
First Posted : December 17, 2003
Last Update Posted : September 29, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Systemic Sclerosis Scleroderma |
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.
Study Type : | Observational |
Estimated Enrollment : | 5000 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Scleroderma Family Registry and DNA Repository |
Study Start Date : | September 2000 |
Estimated Primary Completion Date : | January 2022 |

Group/Cohort |
---|
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
|
- Establish National registry of Scleroderma as resource for scleroderma scientific community [ Time Frame: ongoing ]
Biospecimen Retention: Samples With DNA

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074568
Contact: Jason Anderson | 713-500-7196 |
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 |
Principal Investigator: | Maureen D. Mayes, MD, MPH | The University of Texas Health Science Center, Houston |
Responsible Party: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00074568 |
Other Study ID Numbers: |
NIAMS-108 N01AR002251-000 ( U.S. NIH Grant/Contract ) NO1-AR-0-2251 |
First Posted: | December 17, 2003 Key Record Dates |
Last Update Posted: | September 29, 2020 |
Last Verified: | November 2019 |
Genetic Study Transmission Dysequilibrium Testing Genome Wide Scan Family Study |
Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Connective Tissue Diseases Skin Diseases |