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OpenTrials
Completed

NCT Number: NCT00869479

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

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.

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Key information

Conditions

Nephrogenic Systemic Fibrosis Fibrosis Nephrogenic Fibrosing Dermopathy Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases.

    Time frame: 1 day

  2. Sensitivity of the questionnaire when applied to NSF subjects.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 26, 2009
Registry last updated
Dec 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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