Morbidity and Mortality Follow Up for the Scleroderma Lung Study
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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 |
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Recruitment Status :
Completed
First Posted : January 7, 2013
Last Update Posted : January 23, 2014
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Sponsor:
Duke University
Information provided by (Responsible Party):
Duke University
| Tracking Information | ||||||||||
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| 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 |
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. |
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| 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 |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
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:
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| Sex/Gender |
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| 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 |
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| PRS Account | Duke University | |||||||||
| Verification Date | January 2014 | |||||||||