Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 95
- Locations
- 4
- Primary Endpoint
- Area under the ROC curve for PLTP in the occurrence of GVHD
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported