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

Mass General Brigham

Status: Completed

Conditions: Nephrogenic Systemic Fibrosis

Study type: Observational

Funder types: Other

Identifiers

NCT00869479

2008P002371

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 4 patient groups

1

Description:

subjects with a histologically-proven diagnosis of NSF

2

Description:

subjects with other fibrosing skin diseases

3

Description:

subjects with non-fibrosing skin diseases

4

Description:

subjects without skin diseases