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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03918343

Collaborator

(none)

Enrollment

Locations

Arm

53.8

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hematologic Diseases Stem Cell Transplantation	Other: Blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 6, 2019

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: All patients	Other: Blood sample blood samples (4 times; 14ml per visit)

Arm

Intervention/Treatment

Other: All patients

Other: Blood sample

blood samples (4 times; 14ml per visit)

Outcome Measures

Primary Outcome Measures

Area under the ROC curve for PLTP in the occurrence of GVHD [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Besançon	Besançon		France	25000
2	Centre Hospitalier Universitaire de Nancy	Nancy		France	54 000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Etienne Daguindau, MD, CHU Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT03918343

Other Study ID Numbers:

P/2018/387

First Posted:

Apr 17, 2019

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hematologic Diseases

Graft vs Host Disease

Study Results

No Results Posted as of Apr 6, 2022