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.