Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00869479
First received: March 17, 2009
Last updated: December 14, 2010
Last verified: December 2010
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Purpose
The Primary Aim of this study is to validate a questionnaire as a screening tool to identify subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators believe that there will be difference between subjects with NSF and other skin conditions and normal skin.
| Condition |
|---|
|
Nephrogenic Systemic Fibrosis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Validation of a Questionnaire as a Screening Tool to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Sensitivity of the questionnaire when applied to NSF subjects. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
subjects with a histologically-proven diagnosis of NSF
|
|
2
subjects with other fibrosing skin diseases
|
|
3
subjects with non-fibrosing skin diseases
|
|
4
subjects without skin diseases
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Massachusetts General Hospital Dermatology and Rheumatology clinics
Criteria
Inclusion Criteria:
- Male or female subjects 18 years of age or older.
- Willing and able to understand and provide oral informed consent.
- Able to complete study and comply with study procedures.
Exclusion Criteria:
- Subject is unable to provide oral consent.
- Psychiatric or other conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869479
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Jonathan Kay, MD | Massachusetts General Hospital |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alexandra Kimball, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00869479 History of Changes |
| Other Study ID Numbers: | 2008P002371 |
| Study First Received: | March 17, 2009 |
| Last Updated: | December 14, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Nephrogenic Systemic Fibrosis Screening |
Additional relevant MeSH terms:
|
Fibrosis Signs and Symptoms Nephrogenic Fibrosing Dermopathy Pathologic Processes Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013