NCT07508345

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 4, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 24, 2026

Last Update Submit

March 30, 2026

Conditions

GVHD

Outcome Measures

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.

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 2, 2026

Study Start

June 4, 2021

Primary Completion

July 31, 2022

Study Completion

July 31, 2023

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

IT(1)