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Can Immune Parameters Predict Acute and Chronic Rejection in Lung Recipients?

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ClinicalTrials.gov Identifier: NCT00340951
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

This study will evaluate the ability of lung transplant recipients to react to the transplanted organs. Previous research indicates that some immune tests can identify whether people are at risk for chronic rejection of transplanted lungs. Certain parameters, that is, physical properties involving the immune system, may cause acute chronic rejection of the lungs, which may lead to chronic rejection, a condition of scarring that worsens lung function. If such parameters can be identified and distinguished from those found in healthy subjects, information gained can help medical professionals to provide individualized treatments that work on the immune system. Short-term and long-term survival of lung transplant recipients may thus be improved.

Patients who will have or have had lung transplants will be recruited by clinical transplant coordinators. Normal control subjects will be recruited through flyers and newspaper advertisements.

Collection of blood samples will be done at Duke University Medical Center. Blood collections will be done of patients undergoing routine pretransplant and posttransplant blood tests, so no extra blood collections will be required. Control subjects will undergo three blood collections over an 8-week period. They will be compensated for their time in participating, at the rate of $5 for the initial blood draw, $10 for the second one, and $15 for the third one. A small amount of blood is involved, about 3 tablespoons. The blood cells and DNA (which contains genetic material) will be isolated for analysis. Patients' DNA samples collected will be identified by a code, and all other identifying information will be removed. The samples may be used in the future as new tests are developed.

This study will not have a direct benefit for participants. However, during the study, if it is found that any patients have an inherited risk for a disease likely to cause early death if the disease is not treated, then the researchers will attempt to notify those patients. Overall, it is hoped that information gathered will enhance researchers' understanding of what tests best identify patients at risk for developing chronic rejection of their transplanted lungs.

Condition or disease
Lung Transplantation

Detailed Description:
The aim of this study is to provide insight into the immune mechanisms involved in the pre- and posttransplant response of lung recipients to determine if short- and long-term graft outcome can be predicted and to allow for potential intervention. We have assembled a panel of assays that will test various functions of the immune response and investigate immune mechanisms involved in acute and chronic rejection (CR). Our overall hypothesis is that measurment of pre- and posttransplant immune response to donor HLA antigens/peptides can predict graft outcome. Our goal is to determine if immune parameters [ELISpot], intracellular T regulatory cells and ATP synthesis can identify lung recipients at high risk for developing AR and sub-clinical rejection. Sub-aim: To determine the correlation of cytokine genotypes with ELISpot results and T regulatory cell level and activity for recipients at high risk for developing acute rejection in comparison to a normal subject cohort. A second hypothesis is that recipients who experience an AR episode and remain responsive to donor antigen and those who show increased reactivity to donor HLA peptides are at high risk for developing CR. Our goal is to determine if the immune parameters (CFSE responder frequencies and response to donor peptides are assayed by CFSE, ELISpot, T regulatory cell level, and ATP synthesis) can identify lung recipients at high risk for developing CR and distinguish these immune parameters from a normal subject cohort. If successful, we will provide clinicians with the information necessary for individualization of immunosuppression intervention aimed at improving short and long-term graft outcome.

Study Type : Observational
Estimated Enrollment : 400 participants
Official Title: Can Immune Parameters Predict Acute and Chronic Rejection in Lung Recipients?
Study Start Date : June 23, 2005
Estimated Study Completion Date : April 13, 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Adult patients undergoing transplant at Duke Medical Center are to be recruited as subjects.

In addition, investigators will recruit 80 adult control subjects from individuals who will not have lung disease and will not be on immunosuppression or from pre transplant subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340951

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)

ClinicalTrials.gov Identifier: NCT00340951     History of Changes
Other Study ID Numbers: 999905183
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: April 13, 2007

Keywords provided by National Institutes of Health Clinical Center (CC):
Regulatory T Cells
Bronchiolitis Obliterans Syndrome
Genetic Polymorphism
Innate Immunity
Lung Transplantation