Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02892292 |
| Other study ID # |
NGS-HLA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 2, 2016 |
| Last updated |
September 2, 2016 |
| Start date |
July 2014 |
| Est. completion date |
May 2015 |
Study information
| Verified date |
September 2016 |
| Source |
University Hospital, Brest |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
France: The Commission nationale de l’informatique et des libertés |
| Study type |
Observational
|
Clinical Trial Summary
The objective of this study is to realize the typing of all HLA loci and validate this
technique with continued optimization of next-generation sequencing technology (NGS).
Description:
The number of patients waiting allograft of hematopoietic stem cells is constantly evolving.
Similarly, the number of voluntary donors of hematopoietic stem cells on all global file has
exceeded the threshold of 22 million donors since the end of 2013. Despite this, the search
for a matched unrelated donor HLA for a patient remains sometimes a long and difficult,
especially for patients with rare HLA alleles. It is important to increase the number of
donors in the global file, increase HLA diversity of registrants and resolution HLA typing.
More HLA typing of a donor registered on the file will be accurate, more research and the
recruitment of a donor in order to achieve an allograft in a patient waiting will be fast.
The constant evolution of the number of HLA alleles and the number of ambiguities quickly
demonstrates the limits of current typing techniques. The study of exons and introns that
would significantly refine the level of resolution HLA typing, reaching a level of allelic
resolution. That level of resolution would also identify all null alleles (alleles from
which the protein is not expressed). The search for an HLA with a patient will be made
easier by reducing the financial impact and time of the search. In addition, numerous
studies have shown that tissue compatibility narrowest possible between the donor and
recipient of an allogeneic haematopoietic stem cells can improve patient survival by
reducing the incidence and severity of disease graft against the host and to improve
engraftment.
In addition, analysis capability of the many sample using this technique should induce the
decrease in HLA typing costs and thus facilitate the registration of anonymous bone marrow
donors on the national register of the Biomedicine Agency .
