- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02892292
NGS for HLA Typing of Donors and récipients oh Hematopoietic Stem Cells (NGS HLA)
Next Generation Sequencing (NGS) Application for HLA Typing of Donors and Recipients of Hematopoietic Stem Cells
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brest, France, 29609
- CHRU de Brest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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10 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Virginie Moalic-Allain, Doctor, CHRU de Brest
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NGS-HLA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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