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

This study is ongoing, but not recruiting participants.

First Received: March 17, 2009 Last Updated: March 25, 2009 History of Changes

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00869479

Purpose

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.

Condition
Nephrogenic Systemic Fibrosis

MedlinePlus related topics: Skin Conditions

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional
Official Title:	Validation of a Questionnaire as a Screening Tool to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Sensitivity of the questionnaire when applied to NSF subjects. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 subjects with a histologically-proven diagnosis of NSF
2 subjects with other fibrosing skin diseases
3 subjects with non-fibrosing skin diseases
4 subjects without skin diseases

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Massachusetts General Hospital Dermatology and Rheumatology clinics

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869479

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Jonathan Kay, MD

Massachusetts General Hospital

More Information

Publications:

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

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.

Responsible Party:	Massachusetts General Hospital ( Jonathan Kay, MD )
Study ID Numbers:	2008P002371
Study First Received:	March 17, 2009
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00869479 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Nephrogenic Systemic Fibrosis
Screening

Study placed in the following topic categories:

Signs and Symptoms
Fibrosis
Nephrogenic Systemic Fibrosis

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Fibrosis

ClinicalTrials.gov processed this record on May 07, 2009