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

Massachusetts General Hospital1 site in 1 country60 target enrollmentMarch 2009

ConditionsNephrogenic Systemic Fibrosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nephrogenic Systemic Fibrosis
Sponsor: Massachusetts General Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

September 2010

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•Male or female subjects 18 years of age or older.
•Willing and able to understand and provide oral informed consent.
•Able to complete study and comply with study procedures.

Exclusion Criteria

•Subject is unable to provide oral consent.
•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.

Outcomes

Primary Outcomes

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 Outcomes

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)