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CompletedNCT07508345END-GAMEUpdated Apr 2, 2026

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

An observational study in GVHD, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Completed at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • GVHD
03

In context

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 255 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Age \< 18 years or >70 years
  • Patients receiving allogeneic HSC transplantation for non-hematologic disease
  • Second or subsequent allogeneic HSC transplantation
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Predict the risk of aGvHD onset.

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

    Time frame: During the 18-month enrollment period, approximately 50 adult patients receiving HSCT are expected to be enrolled.

07

Study locations

1 site
  • Fondazione IRCCS Policlinico San Matteo di Pavia
    Pavia, Pavia 27100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07508345
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Responsible party
Luca Arcaini (MD, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
Apr 2, 2026
Start date
Jun 4, 2021
Primary completion
Jul 31, 2022
Completion
Jul 31, 2023
Last update
Apr 2, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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