Morbidity and Mortality Follow Up for the Scleroderma Lung Study

NCT ID: NCT01762449

Last Updated: 2014-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-08-31

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 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.

Conditions

Scleroderma

Study Design

• Observational Model Type: COHORT

Study Groups

Patients who received cyclophosphamide

Patients who received cyclophosphamide on the Scleroderma Lung Study

Followup survey

Intervention Type: OTHER

Patients who received placebo

Patients who received placebo on the Scleroderma Lung Study

Followup survey

Intervention Type: OTHER

Interventions

Followup survey

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participation in the Scleroderma Lung Study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith Sullivan, MD

Role: STUDY_CHAIR

Duke University

Daniel Furst, MD

Role: STUDY_CHAIR

University of California, Los Angeles

Donald Tashkin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Other Identifiers

Pro00026357

Identifier Type: -

Identifier Source: org_study_id