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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
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nephrogenic Fibrosing Dermopathy
Signs and Symptoms
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014