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

Not Applicable

• Conditions: Hematologic Diseases; Stem Cell Transplantation
• Interventions: Other: Blood sample

• Registration Number: NCT03918343
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-17
• Study Start: 2019-09-06
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06
• Primary Completion: 2023-05
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Area under the ROC curve for PLTP in the occurrence of GVHD	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	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.

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France

Centre Hospitalier Universitaire de Nancy; 🇫🇷 Nancy, France