GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection (LTXGERD)
| Tracking Information | |||||
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| First Received Date ICMJE | April 2, 2007 | ||||
| Last Updated Date | January 26, 2010 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00455078 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection | ||||
| Official Title ICMJE | The Role of Reflux in Innate Immunity Activation After Lung Transplantation. | ||||
| Brief Summary | Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and potentially increase the risk of chronic rejection (CR) after lung transplantation. The purpose of this study is to look at how often GER occurs in the lung transplant population and examine how GER may change the immune system and cause CR. In this way, we would be able to better identify patients that may benefit from anti-reflux procedures. |
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| Detailed Description | Part of standard pre-transplant work up includes a gastrointestinal (GI) work-up to check for GER. The following procedures will be done pre-transplant.
These procedures will be done again at 3 to 6 months post transplant. The results of the EGD, scintigraphic evaluation, answers of RDQ, pH testing, esophageal manometry and bronchoscopy will be collected as well as spirometries and any episodes of rejection. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects who have undergone pretransplant evaluation and are on the waiting list or subjects transplanted < 18mos. |
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| Condition ICMJE | Gastroesophageal Reflux | ||||
| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||
| 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 ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00455078 | ||||
| Other Study ID Numbers ICMJE | 15272A | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sangeeta Bhorade, University of Chicago Hospitals | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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