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NCT02414113 · ClinicalTrials.gov registry record
Study for the Evaluation of a GVHD Negative Outcome Score (GNOS) in Matched Unrelated or Haploidentical Hematopoietic Stem Cell Transplant
A clinical trial, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- 113
- Enrollment target
NCT02414113: Completed study, sponsored by Washington University School of Medicine.
NCT02414113 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 113 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02414113 has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- 113 participants
- Enrollment target
Study Summary
Before considering high-GVHD Negative Outcome Score (GNOS) donor selection for routine clinical practice, this blinded prospective study will be carried out for assessment of severe GVHD (graft-versus-host-disease) reduction associated with selecting high-GNOS donors for allogeneic hematopoietic peripheral blood stem cell transplant. The objective of this prospective study is to show: (a) that GVHD reductions and donor availabilities as observed in the retrospective studies also apply to prospective samples that are collected and processed from on-going matched unrelated transplants, and (b) that high-GNOS donor selection readily fits into today's donor selection process, such as to facilitate access to the benefits of GVHD reduction. The prospective study is designed to be blinded, and will not involve specific donor selection nor any influence on clinical management or decision making by application of the GNOS technology. To determine if some GNOS models perform better than others across different clinical centers, or across different recipient / donor attributes, 4 different specific GNOS models will be evaluated. Bootstrap computational analyses have been carried out on the retrospective data for the 4 GNOS models and will be tested and validated in this prospective study.
Primary Outcome
* "GNOS" refers to PBD's proprietary "GVHD Negative Outcome Score" technology for reduction of grades III \& IV aGVHD through donor selection. GNOS is a gene expression-based signature of lower donor allo-reactivity such that transplanted cells from donors displaying higher GNOS will exhibit less allo-reactivity against recipient tissues, therefore decreasing the incidence of severe GVHD. GNOS is determined from pre-transplant, pre-mobilization gene expression profiling of donor CD4 cells from a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2015-03-25 |
| Est. Completion | 2021-01-21 |
What the finished NCT02414113 record still lists
NCT02414113 is an observational study that tracks outcomes without assigning an intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02414113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02414113 about?
NCT02414113 is a clinical study titled "Study for the Evaluation of a GVHD Negative Outcome Score (GNOS) in Matched Unrelated or Haploidentical Hematopoietic Stem Cell Transplant". Before considering high-GVHD Negative Outcome Score (GNOS) donor selection for routine clinical practice, this blinded prospective study will be carried out for assessment of severe GVHD (graft-versus-host-disease) reduction associated with selecting high-GNOS donors for allogeneic hematopoietic per...
What is the current status of trial NCT02414113?
This trial is currently completed. The enrollment target is 113 participants. The study started on 2015-03-25. Estimated completion is 2021-01-21.
Who is sponsoring clinical trial NCT02414113?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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