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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00869479
Other study ID # 2008P002371
Secondary ID
Status Completed
Phase N/A
First received March 17, 2009
Last updated December 14, 2010
Start date March 2009
Est. completion date September 2010

Study information

Verified date December 2010
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Time Perspective: Cross-Sectional


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in the number of "yes" answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases. 1 day No
Secondary Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases. 1 day No
Secondary Sensitivity of the questionnaire when applied to NSF subjects. 1 day No
See also
  Status Clinical Trial Phase
Completed NCT00981942 - Treatment of Patients With Nephrogenic Systemic Fibrosis With Glivec Phase 3
Completed NCT01135316 - Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR N/A
Active, not recruiting NCT00677092 - Pilot Study of Imatinib Mesylate to Treat Nephrogenic Systemic Fibrosis Phase 2
Enrolling by invitation NCT01359345 - Nephrogenic Systemic Fibrosis With Gadollinum Phase 2/Phase 3
Withdrawn NCT00811863 - Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection N/A
Terminated NCT01078987 - Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF) Phase 4
Completed NCT01014754 - Nephrogenic Systemic Fibrosis (NSF): Analysis of Tissue Gadolinium Levels N/A