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.

Study Overview

• Status: Completed
• Conditions: Nephrogenic Systemic Fibrosis

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Massachusetts General Hospital Dermatology and Rheumatology clinics

Description

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.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases.	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases.	1 day
Sensitivity of the questionnaire when applied to NSF subjects.	1 day

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jonathan Kay, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Todd DJ, Kay J. Nephrogenic systemic fibrosis: an epidemic of gadolinium toxicity. Curr Rheumatol Rep. 2008 Jul;10(3):195-204. doi: 10.1007/s11926-008-0033-6.
• Todd DJ, Kagan A, Chibnik LB, Kay J. Cutaneous changes of nephrogenic systemic fibrosis: predictor of early mortality and association with gadolinium exposure. Arthritis Rheum. 2007 Oct;56(10):3433-41. doi: 10.1002/art.22925.
• Lima XT, Alora-Palli MB, Kimball AB, Kay J. Validation of a screening instrument for nephrogenic systemic fibrosis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):637-42. doi: 10.1002/acr.21877.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: March 17, 2009
• First Submitted That Met QC Criteria: March 25, 2009
• First Posted (Estimate): March 26, 2009

Study Record Updates

• Last Update Posted (Estimate): December 15, 2010
• Last Update Submitted That Met QC Criteria: December 14, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Screening; Nephrogenic Systemic Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Fibrosis; Nephrogenic Fibrosing Dermopathy
• Other Study ID Numbers: 2008P002371

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No