LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.
NCT06018766
Bronchial Diseases, Bronchiolitis
San Francisco, California, United States
View Trial DetailsNCT Number: NCT03474536
The aim is to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific Antibodies (DSA), determined at the time of their discovery by surface plasmon resonance (SPR), between recipients that developed a Chronic Lung Allograft Dysfunction (CLAD) for the 2 years following DSA apparition and those who did not. If concentration, kinetics and/or affinity parameters of anti-DQ DSA are associated with CLAD development, new, non-invasive prognostic biomarkers of humoral rejection in lung transplantation will be discovered .
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Notify Me18 year and older
All sexes
Observational
CHU Bordeaux, Bordeaux, France
After lung transplantation the production of de novo DSA directed against HLA-DQ molecules is associated with CLAD and graft loss. The most used assay for serum DSA detection is the Single Antigen Luminex® (SAG), which provides a semi-quantitative fluorescence value, the MFI, used as a surrogate of DSA "strength". But MFI is not perfectly associated with CLAD development. We developed a method using SPR allowing the concentration, kinetics (ka, kd) and affinity parameters (KD) of anti-DQ DSA to be determined. These quantitative parameters could represent biomarkers finely associated with CLAD. The way this parameters evolve (stability, increase or decrease) with time could also impact on DSA pathogenicity. We will compare the quantitative parameters of de novo anti-HLA DQ DSA, determined at the time of their discovery, between recipients that developed a CLAD for the 2 years following DSA apparition, and those who did not. The association between quantitative parameters of DSA and graft loss, their evolution and its association with CLAD and graft loss, and their correlation with SAG MFI will be also evaluated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
CLAD development within the 2 years following DSA apparition
Time frame: 6 months, 1 year, 2 years, 5 years
Graft loss up to 5 years following DSA apparition, defined by re-transplantation or recipient's death
Time frame: 6 months
CLAD development 6 months following DSA apparition
Time frame: 1 year
CLAD development 1 year following DSA apparition
University Hospital, Bordeaux
Other
Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P
Acronym: AFFIHLA-P
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