Morbidity and Mortality Follow Up for the Scleroderma Lung Study

• ClinicalTrials.gov Identifier: NCT01762449
• Recruitment Status: Completed
• First Posted: January 7, 2013
• Last Update Posted: January 23, 2014
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment
Scleroderma	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 Design

• Study Type: Observational
• Actual Enrollment: 158 participants
• Observational Model: Cohort
• Official Title: Morbidity and Mortality Follow Up of Participants of the Scleroderma Lung Study 1
• Study Start Date: July 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: August 2013

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Time to death or first organ failure [ Time Frame: 9-12 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients who participated in the Scleroderma Lung Study

Criteria

Inclusion Criteria:

• Participation in the Scleroderma Lung Study

Contacts and Locations

Sponsors and Collaborators

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

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01762449
• Other Study ID Numbers: Pro00026357
• First Posted: January 7, 2013
• Last Update Posted: January 23, 2014
• Last Verified: January 2014

Keywords provided by Duke University:

Scleroderma; interstitial lung disease

Additional relevant MeSH terms:

Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Connective Tissue Diseases; Skin Diseases