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Morbidity and Mortality Follow Up for the Scleroderma Lung Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01762449
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : January 23, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date January 4, 2013
First Posted Date January 7, 2013
Last Update Posted Date January 23, 2014
Study Start Date July 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2013)
Time to death or first organ failure [ Time Frame: 9-12 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Morbidity and Mortality Follow Up for the Scleroderma Lung Study
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 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
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who participated in the Scleroderma Lung Study
Condition Scleroderma
Intervention Other: Followup survey
Study Groups/Cohorts
  • Patients who received cyclophosphamide
    Patients who received cyclophosphamide on the Scleroderma Lung Study
    Intervention: Other: Followup survey
  • Patients who received placebo
    Patients who received placebo on the Scleroderma Lung Study
    Intervention: Other: Followup survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2013)
158
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participation in the Scleroderma Lung Study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01762449
Other Study ID Numbers Pro00026357
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor Duke University
Original Study Sponsor Same as current
Collaborators Not Provided
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
PRS Account Duke University
Verification Date January 2014