Back to resultsLipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation (MetAlloLip)
Primary Purpose
Hematologic Diseases, Stem Cell Transplantation
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional other trial for Hematologic Diseases
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Universitaire de BesançonRecruiting
- Centre Hospitalier Universitaire de Nancy
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03918343
First Posted
April 15, 2019
Last Updated
April 5, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT03918343
Brief Title
Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Acronym
MetAlloLip
Official Title
Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases, Stem Cell Transplantation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
blood samples (4 times; 14ml per visit)
Primary Outcome Measure Information:
Title
Area under the ROC curve for PLTP in the occurrence of GVHD
Description
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.
Time Frame
3 months
Title
Area under the ROC curve for LPS in the occurrence of GVHD
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charline Vauchy, PhD
Phone
+33381218875
Email
cvauchy@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne Daguindau, MD
Organizational Affiliation
CHU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Daguindau, MCU-PH
Facility Name
Centre Hospitalier Universitaire de Nancy
City
Nancy
ZIP/Postal Code
54 000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Thérèse Rubio, PU-PH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
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