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Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis

This study has been completed.
Information provided by:
Massachusetts General Hospital Identifier:
First received: March 17, 2009
Last updated: December 14, 2010
Last verified: December 2010
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.

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 ]

Secondary Outcome Measures:
  • Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases. [ Time Frame: 1 day ]
  • Sensitivity of the questionnaire when applied to NSF subjects. [ Time Frame: 1 day ]

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)
subjects with a histologically-proven diagnosis of NSF
subjects with other fibrosing skin diseases
subjects with non-fibrosing skin diseases
subjects without skin diseases


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Massachusetts General Hospital Dermatology and Rheumatology clinics

Inclusion Criteria:

  1. Male or female subjects 18 years of age or older.
  2. Willing and able to understand and provide oral informed consent.
  3. Able to complete study and comply with study procedures.

Exclusion Criteria:

  1. Subject is unable to provide oral consent.
  2. 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.
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Please refer to this study by its identifier: NCT00869479

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Jonathan Kay, MD Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alexandra Kimball, MD, Massachusetts General Hospital Identifier: NCT00869479     History of Changes
Other Study ID Numbers: 2008P002371
Study First Received: March 17, 2009
Last Updated: December 14, 2010

Keywords provided by Massachusetts General Hospital:
Nephrogenic Systemic Fibrosis

Additional relevant MeSH terms:
Signs and Symptoms
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Skin Diseases processed this record on May 25, 2017