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Trial record 6 of 16 for:    HLA-DRB1 AND DRB1

NGS for HLA Typing of Donors and récipients oh Hematopoietic Stem Cells (NGS HLA)

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ClinicalTrials.gov Identifier: NCT02892292
Recruitment Status : Completed
First Posted : September 8, 2016
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief 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).

Condition or disease
Next Generation Sequencing for HLA Typing

Detailed 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 .


Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Next Generation Sequencing (NGS) Application for HLA Typing of Donors and Recipients of Hematopoietic Stem Cells
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015



Primary Outcome Measures :
  1. HLA high resolution sequencing for loci HLA-A, HLA-B, HLA-C, HLA-DRB1, HLA-DQB1 and HLA-DPB1. [ Time Frame: 10 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Bone marrow donors-recipients of Brest University Hospital
Criteria

Inclusion Criteria:

  • Bone marrow donors from Brest University Hospital
  • Bone marrow recipients of Brest University Hospital

Exclusion Criteria:

  • No bone marrow donors from Brest University Hospital
  • No bone marrow recipients of Brest University Hospital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892292


Locations
France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Virginie Moalic-Allain, Doctor CHRU de Brest

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02892292     History of Changes
Other Study ID Numbers: NGS-HLA
First Posted: September 8, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016