- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studiecontact
- Naam: Jean-Luc TAUPIN, Pr
- Telefoonnummer: +331 42 49 90 81
- E-mail: jean-luc.taupin@aphp.fr
Studie Contact Back-up
- Naam: Sylvie Chevret, Pr
- Telefoonnummer: +33142499742 +33142499742
- E-mail: sylvie.chevret@paris7.jussieu.fr
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Proportion of serum-specific donor antibodies (DSA)
Tijdsspanne: at 2 years after organ transplantation
|
Proportion of serum-specific donor antibodies (DSA) regarding epitope mismatches
|
at 2 years after organ transplantation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Proportion of dnDSA anti-HLA
Tijdsspanne: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Proportion of dnDSA anti-HLA
Tijdsspanne: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Proportion of dnDSA anti-HLA
Tijdsspanne: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Proportion of non-DSA anti-HLA antibodies
Tijdsspanne: at 2 years after organ transplantation
|
at 2 years after organ transplantation
|
Proportion of non-DSA anti-HLA antibodies
Tijdsspanne: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Proportion of non-DSA anti-HLA antibodies
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Survival of the graft
Tijdsspanne: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Survival of the graft
Tijdsspanne: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Overall survival
Tijdsspanne: at 5 years after organ transplantation
|
at 5 years after organ transplantation
|
Overall survival
Tijdsspanne: at 8 years after organ transplantation
|
at 8 years after organ transplantation
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- NI16035HLJ
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op DNA sequencing called "new generation" (or NGS)
-
Gritstone bio, Inc.VoltooidGemetastaseerde colorectale kanker | Stadium II/III darmkankerVerenigde Staten