Clinical Trial: Morbidity and Mortality Follow Up for the Scleroderma Lung Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Morbidity and Mortality Follow Up of Participants of the Scleroderma Lung Study 1

Brief Summary: The primary intent of this study is to add to the body of knowledge on scleroderma patients with interstitial lung disease. While lung disease is recognized as the leading cause of death amongst patients with scleroderma, there is not a large body of literature describing the long-term morbidity and mortality rate of these scleroderma patients. For this reason, the investigators are following participants of the Scleroderma Lung Study (NCT00004563) after their participation in that study was concluded. In addition, the investigators will assess if the subjects who received one year of oral cyclophosphamide in the Scleroderma Lung Study experienced progression of their scleroderma-related lung disease following the end of the study.

Detailed Summary:

Retrospective and prospective data will be collected about patients who participated in the Scleroderma Lung Study (SLS). An attempt will be made to include all of the participants of the Scleroderma Lung Study, who were reported as alive at the end of that study.

A total of 158 subjects (79 per treatment arm) were randomized on the original Scleroderma Lung Study. Of those, 109 subjects completed the study. A single telephone interview with the participants to assess the occurrence of severe events and a review of the participant's medical records may be conducted. The outcome information will be combined with information collected about all participants in the SLS study. The data being collected includes information on mortality, development of cancers, development of organ failure, and performance status.

Sponsor: Duke University

Current Primary Outcome: Time to death or first organ failure [ Time Frame: 9-12 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Duke University

Dates:
Date Received: January 4, 2013
Date Started: July 2012
Date Completion:
Last Updated: January 22, 2014
Last Verified: January 2014