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Clinical Trials/NCT03918343
NCT03918343CompletedNot Applicable

Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Centre Hospitalier Universitaire de Besancon4 sites in 1 country95 target enrollmentStarted: September 6, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
95
Locations
4
Primary Endpoint
Area under the ROC curve for PLTP in the occurrence of GVHD

Study Overview

Brief Summary

This study is designed to assess the hypothesis that the lipopolysaccharide (LPS) activity index can be quantified early after transplantation, as well as the the PhosphoLipid Transfer Protein (PLTP) activity and these both biological variables are independent variables for predicting the risk of severe Graft versus Host Disease (GVHD).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Hematologic malignancy in complete remission
  • Patients eligible for allogeneic hematopoietic cell transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
  • Regular follow-up in the center

Exclusion Criteria

  • Treatment with a statin in progress
  • Umbilical cord blood transplantation
  • Hemoglobin level less than or equal to 8g / dl
  • Known chronic inflammatory bowel disease or gastroenteritis at the time of inclusion.
  • Chronic enteropathy with Clostridium Difficile

Outcomes

Primary Outcomes

Area under the ROC curve for PLTP in the occurrence of GVHD

Time Frame: 3 months

Area under the ROC curve (AUCROC) for PLTP assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.

Area under the ROC curve for LPS in the occurrence of GVHD

Time Frame: 3 months

Area under the ROC curve (AUCROC) for LPS assessed at day 0 (day of transplantation) in the occurrence of GVHD (grade II-IV) at 3 months post-transplant.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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