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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869479
First Posted: March 26, 2009
Last Update Posted: December 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Massachusetts General Hospital
  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 ]

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)
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

Information from the National Library of Medicine

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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
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: March 17, 2009
First Posted: March 26, 2009
Last Update Posted: December 15, 2010
Last Verified: December 2010

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