Morbidity and Mortality Follow Up for the Scleroderma Lung Study

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

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.

Study Overview

• Status: Completed
• Conditions: Scleroderma
• Intervention / Treatment: Other: Followup survey

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 158

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who participated in the Scleroderma Lung Study

Description

Inclusion Criteria:

• Participation in the Scleroderma Lung Study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who received cyclophosphamide; Patients who received cyclophosphamide on the Scleroderma Lung Study	Other: Followup survey
Patients who received placebo; Patients who received placebo on the Scleroderma Lung Study	Other: Followup survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to death or first organ failure	9-12 years

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Study Chair: Keith Sullivan, MD, Duke University; Study Chair: Daniel Furst, MD, University of California, Los Angeles; Principal Investigator: Donald Tashkin, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Estimate): January 23, 2014
• Last Update Submitted That Met QC Criteria: January 22, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: interstitial lung disease; Scleroderma
• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
• Other Study ID Numbers: Pro00026357