Endothelial Dysfunction as a Predictive Marker of Acute Graft-Versus-Host Disease in Adult Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (END-GAME)

March 30, 2026 updated by: Luca Arcaini, Fondazione IRCCS Policlinico San Matteo di Pavia

Endothelial Dysfunction as a Predictive Marker of Acute Graft-Versus-Host Disease in Adult Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (END-GAME)

Assess whether the CEC count in peripheral blood, analyzed at baseline T0, can predict the risk of acute GvHD onset.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Pavia
      • Pavia, Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with hematological diseases undergoing allogeneic hematopoietic stem cell transplantation at the Hematology Unit of the I.R.C.C.S. Policlinico San Matteo Foundation in Pavia.

Description

Inclusion Criteria:

  • Aged between 18 and 70 years old
  • First allogeneic hematopoietic stem cell (HSC) transplant for hematological disease
  • Use of HSCs from bone marrow, peripheral blood, or cord blood
  • Use of HLA-identical related donors, haploidentical related donors, HLA-identical registry donors, registry donors with mismatches at major HLA loci
  • Signing of informed consent

Exclusion Criteria:

  • Age < 18 years or >70 years
  • Patients receiving allogeneic HSC transplantation for non-hematologic disease
  • Second or subsequent allogeneic HSC transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predict the risk of aGvHD onset.
Time Frame: During the 18-month enrollment period, approximately 50 adult patients receiving HSCT are expected to be enrolled.
Assess whether the CEC count in peripheral blood, analyzed at baseline T0, can predict the risk of acute GvHD onset.
During the 18-month enrollment period, approximately 50 adult patients receiving HSCT are expected to be enrolled.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • END-GAME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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