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

NCT00340951 | Completed

• 2 other identifiers: 99990518305-E-N183
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Transplantation

Keywords

Regulatory T Cells; Bronchiolitis Obliterans Syndrome; Genetic Polymorphism; Innate Immunity; Transplantation; Lung Transplantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 23, 2005
• Study Completion: April 13, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-04-13

Locations

US (2)