Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Centre Hospitalier Universitaire de Besancon95 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hematologic Diseases Stem Cell Transplantation

Interventions

Blood sampleOTHER

blood samples (4 times; 14ml per visit)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Centre Hospitalier Universitaire de Besançon

Besançon, France

Centre Hospitalier Universitaire de Nancy

Nancy, France

Outcomes

Primary Outcomes

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

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.

Time frame: 3 months

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

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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