GVHDEND-GAMENCT07508345
Endothelial Dysfunction as a Predictive Marker of Acute Graft-Versus-Host Disease in Adult Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of GVHD, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Assess whether the CEC count in peripheral blood, analyzed at baseline T0, can predict the risk of acute GvHD onset. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GVHD
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jun 2021to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 18 years or >70 years
- Patients receiving allogeneic HSC transplantation for non-hematologic disease
- Second or subsequent allogeneic HSC transplantation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
About this study
Official title: 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.
- Conditions
- GVHD
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the 18-month enrollment period, approximately 50 adult patients receiving HSCT are expected to be enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start4 Jun 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHDStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Arcaini, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508345
- Sponsor's protocol ID
- END-GAME
- Acronym
- END-GAME
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction as a Predictive Marker of Acute Graft-Versus-Host Disease in Adult Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (END-GAME)
- ClinicalTrials.gov ID
- NCT07508345
- Acronym / sponsor ID
- END-GAME / END-GAME
- Conditions
- GVHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess whether the CEC count in peripheral blood, analyzed at baseline T0, can predict the risk of acute GvHD onset.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years or >70 years
- Patients receiving allogeneic HSC transplantation for non-hematologic disease
- Second or subsequent allogeneic HSC transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GVHD, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.