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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03918343
Acronym
MetAlloLip
Enrollment
95
Registered
2019-04-17
Start date
2019-09-06
Completion date
2025-05-23
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Diseases, Stem Cell Transplantation

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).

Interventions

OTHERBlood sample

blood samples (4 times; 14ml per visit)

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Area under the ROC curve for PLTP in the occurrence of GVHD3 monthsArea 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 GVHD3 monthsArea 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026