Duke Scleroderma Clinic Patient Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Neurology, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/17/2018 |
| Start Date: | April 2016 |
| End Date: | December 2026 |
| Contact: | Ankoor Shah, MD |
| Email: | ankoor.shah@duke.edu |
| Phone: | 919-681-1505 |
The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about
scleroderma. This information could be used in future research to increase the understanding
of disease mechanisms, treatments, and outcomes. This research may also help develop new
therapies, novel measures of disease assessment or identify previously unknown manifestations
of the diseases. A prospectively followed cohort is an integral component of future
translational and clinical research programs. A registry for scleroderma would allow for
information to be gleaned about patients in "real-world situations" in an effort to improve
the reality, generalizability and applicability of information gathered.
scleroderma. This information could be used in future research to increase the understanding
of disease mechanisms, treatments, and outcomes. This research may also help develop new
therapies, novel measures of disease assessment or identify previously unknown manifestations
of the diseases. A prospectively followed cohort is an integral component of future
translational and clinical research programs. A registry for scleroderma would allow for
information to be gleaned about patients in "real-world situations" in an effort to improve
the reality, generalizability and applicability of information gathered.
The Duke Scleroderma Registry (DSScR) will include 3 types of data collected at each standard
of care office visit, generally every 3-6 months. The data will include:
1. Clinical data obtained by clinicians and entered electronically into a secure database
2. Laboratory, procedure, and imaging data obtained over the course of clinical care
3. Photographs of clinically relevant physical findings.
Data that will be stored include historical data on patients' disease and concurrent medical
conditions, physical exam findings, laboratory values, imaging and other diagnostic testing
results, detailed list of medications and treatments, and quality of life questionnaire data.
Historical information will include detailed medical, obstetric, surgical, procedural,
social, and family history of disease comparable to information gathered at a typical initial
visit. No protected health information will be collected or stored on family members. Data
collected will be stored in a secure computer database as well as in a clinic note and will
be used for patient care purposes. Protected health information (PHI) that will accompany
subject data include name, medical record number, address, phone number, date of birth, dates
of diagnoses, dates of procedures, and dates of clinic visits.
The database will be maintained indefinitely; there is no planned endpoint to the collection
of the data and maintenance of the database as the investigators are planning a long term
prospective evaluation of persons with these diseases.
Subjects will be serially approached/recruited from existing patients in the Duke
Rheumatology Adult Clinic. The project will be introduced to each prospective subject by
someone involved in their clinical care. A waiver of consent and Health Insurance Portability
and Accountability Act (HIPAA) authorization has been filed for the Duke Scleroderma
Registry. Persons who have been diagnosed with scleroderma will be identified through
monitoring of outpatient clinic lists and the inpatient consult service.
Research records will be archived upon completion of the study. Subject initials and study
number will be used to identify subjects in the research material and on research specimens.
All electronic data is stored on the shared drive and secured through the following Duke
Health Technology Services approved methods: access rights granted and terminated for
authorized users only, secure laptops and workstations, individual identifier plus password
protection, routine electronic back up, network restrictions.
During the initial screening process, no identifying information (e.g., name, address) will
be kept. During the consent process, participants will be informed of data storage and
confidentiality safeguards, which are practiced according to HIPAA regulations. Each
participant will be assigned a unique identifier (ID) number. All data will be de-identified
and coded with this number only.
of care office visit, generally every 3-6 months. The data will include:
1. Clinical data obtained by clinicians and entered electronically into a secure database
2. Laboratory, procedure, and imaging data obtained over the course of clinical care
3. Photographs of clinically relevant physical findings.
Data that will be stored include historical data on patients' disease and concurrent medical
conditions, physical exam findings, laboratory values, imaging and other diagnostic testing
results, detailed list of medications and treatments, and quality of life questionnaire data.
Historical information will include detailed medical, obstetric, surgical, procedural,
social, and family history of disease comparable to information gathered at a typical initial
visit. No protected health information will be collected or stored on family members. Data
collected will be stored in a secure computer database as well as in a clinic note and will
be used for patient care purposes. Protected health information (PHI) that will accompany
subject data include name, medical record number, address, phone number, date of birth, dates
of diagnoses, dates of procedures, and dates of clinic visits.
The database will be maintained indefinitely; there is no planned endpoint to the collection
of the data and maintenance of the database as the investigators are planning a long term
prospective evaluation of persons with these diseases.
Subjects will be serially approached/recruited from existing patients in the Duke
Rheumatology Adult Clinic. The project will be introduced to each prospective subject by
someone involved in their clinical care. A waiver of consent and Health Insurance Portability
and Accountability Act (HIPAA) authorization has been filed for the Duke Scleroderma
Registry. Persons who have been diagnosed with scleroderma will be identified through
monitoring of outpatient clinic lists and the inpatient consult service.
Research records will be archived upon completion of the study. Subject initials and study
number will be used to identify subjects in the research material and on research specimens.
All electronic data is stored on the shared drive and secured through the following Duke
Health Technology Services approved methods: access rights granted and terminated for
authorized users only, secure laptops and workstations, individual identifier plus password
protection, routine electronic back up, network restrictions.
During the initial screening process, no identifying information (e.g., name, address) will
be kept. During the consent process, participants will be informed of data storage and
confidentiality safeguards, which are practiced according to HIPAA regulations. Each
participant will be assigned a unique identifier (ID) number. All data will be de-identified
and coded with this number only.
Inclusion Criteria:
- Patients with a history of systemic sclerosis or Scleroderma as identified by the 2013
American College of Rheumatology classification criteria
Exclusion Criteria:
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