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

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).

Full Title of Study: “Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2023

Interventions

  • Other: Blood sample
    • blood samples (4 times; 14ml per visit)

Arms, Groups and Cohorts

  • Other: All patients

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Besancon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Etienne Daguindau, MD, Principal Investigator, CHU Besançon
  • Overall Contact(s)
    • Charline Vauchy, PhD, +33381218875, cvauchy@chu-besancon.fr

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