Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340951
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Can Immune Parameters Predict Acute and Chronic Rejection in Lung Recipients
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Can Immune Parameters Predict Acute and Chronic Rejection in Lung Recipients
Status:
COMPLETED
Status Verified Date:
2007-04-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 antigenspeptides 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-E-N183 | None | None | None |