Lung TransplantationNCT00340951
Can Immune Parameters Predict Acute and Chronic Rejection in Lung Recipients?
An observational study of Lung Transplantation, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Transplantation
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Jun 2005to 13 Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
NIEHS, Research Triangle Park
Research Triangle Park, North Carolina, 27709
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Lung Transplantation
- Keywords
- Regulatory T Cells, Bronchiolitis Obliterans Syndrome, Genetic Polymorphism, Innate Immunity, Transplantation, Lung Transplantation
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start23 Jun 2005
- Study completion13 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340951
- Sponsor's protocol ID
- 999905183
- Other IDs
- 05-E-N183
- Status last verified
- 13 Apr 2007
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Immune Parameters Predict Acute and Chronic Rejection in Lung Recipients?
- ClinicalTrials.gov ID
- NCT00340951
- Acronym / sponsor ID
- 999905183
- Conditions
- Lung Transplantation
- Keywords
- Regulatory T Cells, Bronchiolitis Obliterans Syndrome, Genetic Polymorphism, Innate Immunity, Transplantation, Lung Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 23 Jun 2005
- Study completion
- 13 Apr 2007
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017; AzTrials last refreshed its copy on 31 Oct 2026.