An interventional study of Predictor' kit in Hemopathy, sponsored by Imagine Institute. Terminated at 4 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-01.
Sponsored by Imagine Institute · Not applicable, Interventional, and Prevention
This study is a proof of concept that will assess the Predictor's kit performances. The test will be performed by several technicians, in immunological laboratories of several sites in France.
In this study, "couples" of donor / recipient in the frame of a graft of CSH will be included.
The Hematopoietic Stem Cell (HSC) graft is the only curative treatment for lots of hematologic diseases, malignant or not, particularly leukemias.
The acute Graft versus Host (aGvH) reaction is the most frequent complication, and could concern until 50% of recipients. It is mainly linked to immune characteristics of the donor which will act versus the graft recipient.
There is a huge need of a technology that could predict the risk of aGvH, especially in order to select a donor in case of several possibilities, in order to reduce morbidity and mortality of graft.
The Predictor' kit allows to predict acute and severe forms of Graft versus Host disease before the graft of peripheral hematological stem cells, by the assesment of iNKT cells expansion.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 34 is close to the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Imagine Institute is the lead sponsor of 30 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main inclusion Criteria for Donors :
Main inclusion Criteria for Recipient :
Main exclusion Criteria:
Each couple will be treated the same way : An additional blood sample of the donor will be taken prior GCSF mobilization. This blood sample will then be analyzed via Predictor's kit, by the immunology laboratory of the hospital where the graft will be done. Whatever the result given by the Predictor' kit, the graft will be done for the recipient patient. No change will be done on the usual graft process.
Biological: Predictor' kit
Realization of the Predictor' kit on the blood of donor of HSC, in the frame of a graft, to predict a aGvH reaction on recipient patient.
Assessment of the diagnosis test performance
The performance of the test will be assessed via the observation of the number of aGvH 6 months after the graft, reported to the the expansion of iNKT cells. Assessment of sensitivity and specificity of the diagnosis test
Time frame: 6 months
Assessment of the reproductibility of the test
The reproductibility of the test will be assessed by comparing the results obtained by 2 distinct operators : the immunology lab technician, and the referent operator at Imagine Institute research lab. The 2 operators will perform the test in parallel on the blood of the same donor, in similar conditions, and both by using a Predictor's kit.
Time frame: 6 months
This study is terminated, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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