Undifferentiated Connective Tissue Disease Registry (UCTD Registry)

This registry has been established to gain a better understanding of the clinical and emotional presentations of patients with undifferentiated connective tissue disease.

Study Overview

• Status: Recruiting
• Conditions: Undifferentiated Connective Tissue Disease
• Intervention / Treatment: Other: Observation

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Principal Investigator: Lisa Sammaritano, MD
      • Contact: Lucy Masto, BS; Phone Number: 917-260-4968; Email: mastol@hss.edu
      • Contact: Amaya Smole, BA; Phone Number: 212-774-2960; Email: smolea@hss.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients under the care of any HSS rheumatologist that have been diagnosed with undifferentiated connective tissue disease.

Description

Inclusion Criteria:

• Any patient under the care of an HSS rheumatologist
• Positive ANA or a positive anti-ds DNA, anti-Ro/SS-A or other autoantibody on 2 or more occasions at least 12 weeks apart
• One or more signs or symptoms of connective tissue disease, including but not limited to arthralgia, arthritis, myalgia, rash, sicca symptoms, pericarditis, pleuritis, pulmonary symptoms, peripheral neuropathy, photosensitivity, alopecia, oral or nasal ulcers, leucopenia, anemia, and abnormal nailfold capillaroscopy

Exclusion Criteria:

• Patients who meet criteria for well defined CTD including SLE, rheumatoid arthritis, polymyositis or dermatomyositis, systemic sclerosis, or antiphospholipid syndrome
• Patients who are less than 18
• Those unable to give informed consent in English

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Registry Participants; All patients who participate in the UCTD Registry will be put into this cohort and observed over approximately 3 years.	Other: Observation; There are no interventions associated with this registry as it is purely observational.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 4, 2014
• First Posted (Estimated): September 9, 2014

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: registry; connective tissue disease; hospital for special surgery
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Undifferentiated Connective Tissue Diseases
• Other Study ID Numbers: 2014-311; Robin J. Sillau Fund (Other Grant/Funding Number: Robin J. Sillau Fund for Connective Tissue Disease Research)