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| ID | Type | Description | Link |
|---|---|---|---|
| Robin J. Sillau Fund | Other Grant/Funding Number | Robin J. Sillau Fund for Connective Tissue Disease Research |
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This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.
The purpose of this research registry is to gather information about clinical symptoms and laboratory test results in patients with undifferentiated connective tissue disease (UCTD). Analysis of this information may help to better predict the prognosis for patients with this form of autoimmune disease, and may identify risk factors for progression to more specific connective tissue diseases such as systemic lupus. This is done by collecting information from your medical records including clinical history, physical examination, and lab test results, and by asking you questions about specific symptoms you may have such as joint pain, rashes, and other common symptoms of UCTD. This information will be stored in a database, and used at a later time for research studies. All future research studies using information in this registry will be subject to oversight by HSS's Institutional Review Board (which is responsible for oversight of research at HSS involving human subjects). All patients who seek or receive medical care at HSS for undifferentiated connective tissue disease will be invited to participate in this registry.
Most future research studies involving this registry will only use the information in this registry, and therefore will not require the further involvement or additional informed consent of participants in the registry. But the information in this registry may also be used to identify patients who may be eligible to participate in certain future research studies conducted by HSS that relate to their particular disease, condition, or treatment and for which information is needed that is not in the registry. If you are identified (based on information about you in the registry) as being potentially eligible for a future research study that relates to your particular disease, condition, or treatment, you may be contacted to find out if you would be interested in participating in the research study. If you are interested, the research study would be fully explained to you, and you would have to give your informed consent before you could participate. If you participate in this registry, you will not be required to participate in any future research study that HSS contacts you about.
By participating in this registry, you will not be asked to do anything that would not ordinarily be done as a matter of routine care at HSS including clinical assessments, laboratory tests and radiology procedures. During your routine visits we will be recording all of the information about you that relates to your disease, condition, or treatment and will include that information in the registry. Your participation will involve a minimum of one yearly visit at the time of your visit to your own rheumatologist. Most study visits are expected to last 10 - 15 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Registry Participants | All patients who participate in the UCTD Registry will be put into this cohort and observed over approximately 3 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | There are no interventions associated with this registry as it is purely observational. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SF-36 Score | Patient questionnaire that measures health-related quality of life. | 3 years |
| Change in Fatigue Severity Scale Score | Evaluates the impact of fatigue on the patient. | 3 years |
| Change in Beck Depression Inventory Score | Self-reported depression severity questionnaire | 3 years |
| Connective Tissue Disease Criteria | The physician will monitor which characteristics from each connective tissue disease the patient presents with. This will show how UCTD progresses and what the most prominent characteristics of the disease are. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| CBC | Patients may have this clinical lab test ordered to monitor their hemoglobin, hematocrit, and platlet counts. | 3 years |
| Comprehensive Metabolic Panel | Patients may have this clinical laboratory test ordered to monitor their electrolytes, creatinine, glucose levels, phosphates, and blood protein levels. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients under the care of any HSS rheumatologist that have been diagnosed with undifferentiated connective tissue disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | Recruiting | New York | New York | 10021 | United States |
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| ID | Term |
|---|---|
| D000074079 | Undifferentiated Connective Tissue Diseases |
| D003240 | Connective Tissue Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| 3 years |
| Cholesterol Profile | Patients may have this clinical laboratory test ordered to monitor their blood cholesterol levels. | 3 years |
| Urinalysis | Patients may have this clinical laboratory test ordered to monitor their health and the presence of any infections. | 3 years |