- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03861962
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level (ACORG-HLA)
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level: a Track to Improve Organ Allocation
Transplantation is the only treatment for end-stage organ dysfunction, with dialysis for the kidney. However, donor / recipient (D / R) tissue incompatibility accounts for the majority of long-term graft losses, through the development of serum-specific donor antibodies (DSA) to human leukocyte antigens (HLA) of donor, with a prevalence of about 10% at 2 years and 20% at 5 years.
DSA immunization is very often directed against one or a few of the donor's incompatible antigens, suggesting that epitopes (and antigens) are not all equally immunogenic. Identifying HLA epitopes that cause the most and the least immunization would help refine the graft distribution to better manage a limited resource by defining the D / R combinations to avoid or promote. Since the immunogenicity of an HLA epitope depends on the HLA of the recipient given the properties of the epitopes mentioned above, a very large cohort is needed to understand this question. To do so, it is necessary to redo these typings with a method exploring all the genes (add DQA1, DRB3 / 4/5, DPB1 and DPA1) when this has not been done after the graft as part of the standard care. This has become possible since 3 years by DNA sequencing called "new generation" (or NGS), a method that is supplanting all others for the medical care of patients in transplantation.
This study is a retrospective cohort study with 5-year follow-up. The investigators' main objective is to evaluate the predictive value of the number of mismatched HLA epitopes for the development of DSA anti-HLA de novo at 2 years. The investigators' secondary objectives are to evaluate this parameter at 5 and 8 years to determine which epitope mismatches should be favored / avoided in the future.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Jean-Luc TAUPIN, Pr
- Telefonní číslo: +331 42 49 90 81
- E-mail: jean-luc.taupin@aphp.fr
Studijní záloha kontaktů
- Jméno: Sylvie Chevret, Pr
- Telefonní číslo: +33142499742 +33142499742
- E-mail: sylvie.chevret@paris7.jussieu.fr
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- patients (adults and children)
- patients recipients in France from 2008 to 2015 of a first kidney transplant / heart / lung / liver donor living or deceased, non-immunized anti-HLA before the transplant
- patients having preserved their graft > 2 years
- having agreed to the use for research purposes in transplantation of the remains of the DNA and serum samples taken as part of the care of which the remains are available
Exclusion Criteria:
- no inclusion if one of the inclusion criteria is not met
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Proportion of serum-specific donor antibodies (DSA)
Časové okno: at 2 years after organ transplantation
|
Proportion of serum-specific donor antibodies (DSA) regarding epitope mismatches
|
at 2 years after organ transplantation
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Proportion of dnDSA anti-HLA
Časové okno: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Proportion of dnDSA anti-HLA
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Proportion of dnDSA anti-HLA
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Proportion of non-DSA anti-HLA antibodies
Časové okno: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Proportion of non-DSA anti-HLA antibodies
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Proportion of non-DSA anti-HLA antibodies
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Proportion of both total and HLA class I or class II dnDSA by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1) , by HLA antigen, by epitope, for all types of organs and by organ type
Časové okno: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Proportion of both total and HLA class I or class II dnDSA by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1) , by HLA antigen, by epitope, for all types of organs and by organ type
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Proportion of both total and HLA class I or class II dnDSA by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1) , by HLA antigen, by epitope, for all types of organs and by organ type
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Number of dnDSA anti-HLA both total and by HLA class (class I versus class II), by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1), by HLA antigen, for all organ types and organ type
Časové okno: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Number of dnDSA anti-HLA both total and by HLA class (class I versus class II), by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1), by HLA antigen, for all organ types and organ type
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Number of dnDSA anti-HLA both total and by HLA class (class I versus class II), by HLA locus (A, B, C, DRB1, DRB3 / 4/5, DQB1, DQA1, DPB1, DPA1), by HLA antigen, for all organ types and organ type
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Distribution of anti-HLA dnDSA by targeted epitope and antigen (to define immunodominant and non-immunodominant epitopes and antigens), both total and by HLA class (class I versus class II), by HLA locus for all types of organs and organ type
Časové okno: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Distribution of anti-HLA dnDSA by targeted epitope and antigen (to define immunodominant and non-immunodominant epitopes and antigens), both total and by HLA class (class I versus class II), by HLA locus for all types of organs and organ type
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Distribution of anti-HLA dnDSA by targeted epitope and antigen (to define immunodominant and non-immunodominant epitopes and antigens), both total and by HLA class (class I versus class II), by HLA locus for all types of organs and organ type
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Distribution of strength anti-HLA dnDSA measured by mean fluorescence intensity to identify the immunodominant DSA, both global and by class, by HLA locus by HLA antigen, by epitope, for all types of organs and organ type
Časové okno: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Distribution of strength anti-HLA dnDSA measured by mean fluorescence intensity to identify the immunodominant DSA, both global and by class, by HLA locus by HLA antigen, by epitope, for all types of organs and organ type
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Distribution of strength anti-HLA dnDSA measured by mean fluorescence intensity to identify the immunodominant DSA, both global and by class, by HLA locus by HLA antigen, by epitope, for all types of organs and organ type
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ
Časové okno: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Strength in mean fluorescence intensity of dnDSA anti-HLA de novo specific epitopes of epitopes DQbeta, DQalpha and composites (DQbeta + DQalpha) by antigen DQ
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Survival of the graft
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Survival of the graft
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Overall survival
Časové okno: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Overall survival
Časové okno: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- NI16035HLJ
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Transplantace orgánů
-
AiCuris Anti-infective Cures AGQuintiles, Inc.DokončenoHCMV reaktivace nebo HCMV End-Organ DiseaseSpojené státy, Německo
Klinické studie na DNA sequencing called "new generation" (or NGS)
-
Institut National de la Santé Et de la Recherche...Institut Bergonié; Plateforme labellisée Inca - Institut Bergonié, Bordeaux; Plateforme... a další spolupracovníciDokončenoSarkom měkkých tkání | Kolorektální karcinomFrancie