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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00869479

Enrollment

Registered

2009-03-26

Start date

2009-03-31

Completion date

2010-09-30

Last updated

2010-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrogenic Systemic Fibrosis

Keywords

Nephrogenic Systemic Fibrosis, Screening

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.

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

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

Countries

United States

Outcome results