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

Nephrogenic Systemic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869479
• Other study ID #: 2008P002371
• Status: Completed
• Phase: N/A
• First received: March 17, 2009
• Last updated: December 14, 2010
• Start date: March 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2010
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fibrosis
• Nephrogenic Fibrosing Dermopathy
• Nephrogenic Systemic Fibrosis
• Signs and Symptoms

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Todd DJ, Kay J. Nephrogenic systemic fibrosis: an epidemic of gadolinium toxicity. Curr Rheumatol Rep. 2008 Jul;10(3):195-204. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases.		1 day	No
Secondary	Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases.		1 day	No
Secondary	Sensitivity of the questionnaire when applied to NSF subjects.		1 day	No