Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02234388 |
| Other study ID # |
2014-311 |
| Secondary ID |
Robin J. Sillau |
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2012 |
| Est. completion date |
March 31, 2027 |
Study information
| Verified date |
January 2024 |
| Source |
Hospital for Special Surgery, New York |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
This registry has been established to gain a better understanding of the clinical and
emotional presentations of patients with undifferentiated connective tissue disease.
Description:
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.
