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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00869479
First received: March 17, 2009
Last updated: December 14, 2010
Last verified: December 2010

March 17, 2009
December 14, 2010
March 2009
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00869479 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis
Validation of a Questionnaire as a Screening Tool to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis

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.

Not Provided
Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

Massachusetts General Hospital Dermatology and Rheumatology clinics

Nephrogenic Systemic Fibrosis
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00869479
2008P002371
Yes
Alexandra Kimball, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Jonathan Kay, MD Massachusetts General Hospital
Massachusetts General Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP