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

Massachusetts General Hospital60 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Nephrogenic Systemic Fibrosis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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.

Time frame: 1 day

Sensitivity of the questionnaire when applied to NSF subjects.

Time frame: 1 day

Data from ClinicalTrials.gov

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