NCT03918343

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 6, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2025

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

April 15, 2019

Last Update Submit

July 4, 2025

Conditions

Hematologic DiseasesStem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

All patients

OTHER
Other: Blood sample

Interventions

Blood sampleOTHER

blood samples (4 times; 14ml per visit)

All patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Treatment with a statin in progress
  • Umbilical cord blood transplantation
  • Hemoglobin level less than or equal to 8g / dl
  • Chronic enteropathy with Clostridium Difficile

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

Location

Centre Hospitalier Universitaire de Nancy

Nancy, 54 000, France

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Etienne Daguindau, MD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 17, 2019

Study Start

September 6, 2019

Primary Completion

September 1, 2024

Study Completion

May 23, 2025

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)