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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematologic Diseases Hemic and Lymphatic Diseases Stem Cell Transplantation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Besançon, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

blood samples (4 times; 14ml per visit)

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

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

Acronym: MetAlloLip

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2025
First posted: Apr 17, 2019
Registry last updated: Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed