Hematologic Diseases Clinical Trial
— MetAlloLipOfficial title:
Study of Lipopolysaccharide Metabolism for Identification of New 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).
Status | Recruiting |
Enrollment | 98 |
Est. completion date | March 2024 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire de Besançon | Besançon | |
France | Centre Hospitalier Universitaire de Nancy | Nancy |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Besancon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 months | |
Primary | 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. | 3 months |
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