Acute Myeloid Leukemia, AdultNCT06200441
Correlation of Serum Gasdermin-D and NLRP-3 Inflammasome Levels With GVHD Biomarkers and Endothelial Damage Markers in Graft-Versus-Host Disease
An observational study of Acute Myeloid Leukemia, Adult and Graft Versus Host Disease, run by Ugur Arzu Kulu at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to reveal the relationship between serum markers of pyroptosis, GVHD biomarkers and endothelial damage markers in patients who were planned for allogeneic stem cell transplantation for AML and developed GVHD during follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Adult, Graft Versus Host Disease, Endothelial Dysfunction
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 15 Nov 2024
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years and older who underwent allogeneic hematopoteic stem cell transplantation for AML and were followed up by Ankara University Hematology Department
Who may be able to join
- 18 years of age or older
- Patients with acute myeloid leukemia undergoing allogeneic bone marrow transplantation
- Patients followed up by the Department of Hematology, Ankara University Faculty of Medicine Hospitals
Who cannot join
- Patients under 18 years of age
- Patients with non-AML transplant indication
- Patients not followed up by the Department of Hematology, Ankara University Faculty of Medicine Hospitals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Department of Hematology
Ankara, 06000
About this study
Official title: Correlation of Serum Gasdermin-D and NLRP-3 Inflammasome Levels With GVHD Biomarkers and Endothelial Damage Markers in Graft-Versus-Host Disease in AML Patients Undergoing Allogeneic Bone Marrow Transplantation
The investigators aimed to reveal the relationship between serum markers of pyroptosis, GVHD biomarkers and endothelial damage markers in patients who were planned for allogeneic stem cell transplantation for AML and developed GVHD during follow-up. Secondary outcomes of the study were to demonstrate the role of pyroptosis in the pathophysiology of GVHD and transplantation-associated endothelial injury using serum plasma samples; the efficacy of GVHD biomarkers used to demonstrate organ-specific involvement; and the efficacy of GVHD biomarkers and endothelial injury markers in predicting the development of GVHD, transplantation-associated endothelial injury and non-relapse mortality.
Read the detailed description
In the study, in patients who were planned to receive allogeneic stem cell transplantation for AML, pre-transplant period (before and after central catheter insertion) and post-transplant period (+1, +7, +14, +28, +60 and +100 days in the post-transplant period) serum pyroptosis markers (Serum Gasdermin-D and NLRP-3 Inflammasome levels), GVHD biomarkers (REG-3 alpha, ST2, ELAFIN, HGF, ILR2-alpha, CXCL 9, CXCL 10, CXCL11, BAFF, TNF-alpha, I IL8, IL6 , IL18 , I IL1-beta , IL12 , IFN-gamma) and endothelial damage markers (serums-ICAM , sE-selectin , sVCAM , ANG2 , CRP , vWF , Factor 8 , LDH , d-dimer , transaminase enzyme levels and before transplantation, The aim of this study was to determine the relationship between basic biomarkers in pyroptosis and biomarkers with high predictive value in GVHD and markers of endothelial damage in patients who develop GVHD during follow-up using nail bed capillaroscopic examination and fibroelastographic evaluation to be performed on the twenty-first and hundredth days after transplantation.The serum samples obtained will be compared with the groups of patients with and without GVHD at the planned 1-year follow-up.
Patients diagnosed with AML between 15.11.2023 and 15.11.2024 will be included in the study and a total of 2 years of clinical follow-up is planned.
In case of loss of participants during follow-up, the study planned to recruit new patients with AML who were scheduled for transplantation between November 15, 2023 and November 15, 2024.
- Keywords
- Acute Myeloid Leukemia, Adult, Graft Versus Host Disease, Pyroptotic Cell Death, Gasdermin-D, NLR Family, Pyrin Domain-Containing 3 Protein, Endothelial Dysfunction
- Medical subject headings
- Leukemia, Myeloid, Acute, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Developing GVHD | Group of patients who developed GVHD during follow-up in patients who underwent allogeneic hematopoteic stem cell transplantation for AML | |
| non-GVHD | Group of patients who did not develop GVHD during follow-up in patients who received allogeneic hematopoteic stem cell transplantation for AML |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between pyroptosis, GVHD and endothelial damage in allogeneic bone marrow transplant patients
To reveal the relationship between basic biomarkers in pyroptosis and biomarkers with high predictive value in GVHD and endothelial damage markers in AML (acute myeloid leukemia) patients with allogeneic bone marrow transplantation
Measured: The pre- and post-transplant serum samples,capillaroscopic and fibroelastographic examinations will be performed for each participant at the specified time interval until post-transplant 100th day
Secondary outcomes (2)
Efficacy of used GVHD biomarkers in indicating organ-specific involvement
Effect of REG-3 alpha, ELAFIN and HGFs in demonstrating organ specificity in GVHD development
Measured: The pre- and post-transplant serum samples,capillaroscopic and fibroelastographic examinations will be performed for each participant at the specified time interval until post-transplant 100th day
The effectiveness of biomarkers in predicting the development of GVHD, transplant-related endothelial injury, and non-relapse mortality
The effectiveness of the biomarkers in predicting the development of GVHD, transplantation-related endothelial damage, and non-relapse mortality in the planned one-year follow-up
Measured: The pre- and post-transplant serum samples,capillaroscopic and fibroelastographic examinations will be performed for each participant at the specified time interval until post-transplant 100th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Nov 2023
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Why it stopped: Kits were not available due to lack of sponsorship
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ugur Arzu Kulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ugur Arzu Kulu, Ankara University
- Investigators
- Meltem Kurt Yüksel, Study director, Ankara University, Department of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200441
- Sponsor's protocol ID
- AnkaraUniversityMedicine
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Serum Gasdermin-D and NLRP-3 Inflammasome Levels With GVHD Biomarkers and Endothelial Damage Markers in Graft-Versus-Host Disease in AML Patients Undergoing Allogeneic Bone Marrow Transplantation
- ClinicalTrials.gov ID
- NCT06200441
- Acronym / sponsor ID
- AnkaraUniversityMedicine
- Keywords
- Acute Myeloid Leukemia, Adult, Graft Versus Host Disease, Pyroptotic Cell Death, Gasdermin-D, NLR Family, Pyrin Domain-Containing 3 Protein, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Kits were not available due to lack of sponsorship
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ugur Arzu KuluUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 11 Jan 2024 (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.
The investigators aimed to reveal the relationship between serum markers of pyroptosis, GVHD biomarkers and endothelial damage markers in patients who were planned for allogeneic stem cell transplantation for AML and developed GVHD during follow-up. Secondary outcomes of the study were to demonstrate the role of pyroptosis in the pathophysiology of GVHD and transplantation-associated endothelial injury using serum plasma samples; the efficacy of GVHD biomarkers used to demonstrate organ-specific involvement; and the efficacy of GVHD biomarkers and endothelial injury markers in predicting the development of GVHD, transplantation-associated endothelial injury and non-relapse mortality.
Detailed description
In the study, in patients who were planned to receive allogeneic stem cell transplantation for AML, pre-transplant period (before and after central catheter insertion) and post-transplant period (+1, +7, +14, +28, +60 and +100 days in the post-transplant period) serum pyroptosis markers (Serum Gasdermin-D and NLRP-3 Inflammasome levels), GVHD biomarkers (REG-3 alpha, ST2, ELAFIN, HGF, ILR2-alpha, CXCL 9, CXCL 10, CXCL11, BAFF, TNF-alpha, I IL8, IL6 , IL18 , I IL1-beta , IL12 , IFN-gamma) and endothelial damage markers (serums-ICAM , sE-selectin , sVCAM , ANG2 , CRP , vWF , Factor 8 , LDH , d-dimer , transaminase enzyme levels and before transplantation, The aim of this study was to determine the relationship between basic biomarkers in pyroptosis and biomarkers with high predictive value in GVHD and markers of endothelial damage in patients who develop GVHD during follow-up using nail bed capillaroscopic examination and fibroelastographic evaluation to be performed on the twenty-first and hundredth days after transplantation.The serum samples obtained will be compared with the groups of patients with and without GVHD at the planned 1-year follow-up.
Patients diagnosed with AML between 15.11.2023 and 15.11.2024 will be included in the study and a total of 2 years of clinical follow-up is planned.
In case of loss of participants during follow-up, the study planned to recruit new patients with AML who were scheduled for transplantation between November 15, 2023 and November 15, 2024.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Developing GVHD | – | –Group of patients who developed GVHD during follow-up in patients who underwent allogeneic hematopoteic stem cell transplantation for AML |
| non-GVHD | – | –Group of patients who did not develop GVHD during follow-up in patients who received allogeneic hematopoteic stem cell transplantation for AML |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older who underwent allogeneic hematopoteic stem cell transplantation for AML and were followed up by Ankara University Hematology Department
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patients with acute myeloid leukemia undergoing allogeneic bone marrow transplantation
- Patients followed up by the Department of Hematology, Ankara University Faculty of Medicine Hospitals
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Patients with non-AML transplant indication
- Patients not followed up by the Department of Hematology, Ankara University Faculty of Medicine Hospitals
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
The relationship between pyroptosis, GVHD and endothelial damage in allogeneic bone marrow transplant patients
Time frame: The pre- and post-transplant serum samples,capillaroscopic and fibroelastographic examinations will be performed for each participant at the specified time interval until post-transplant 100th day
To reveal the relationship between basic biomarkers in pyroptosis and biomarkers with high predictive value in GVHD and endothelial damage markers in AML (acute myeloid leukemia) patients with allogeneic bone marrow transplantation
2 secondary outcomes
Efficacy of used GVHD biomarkers in indicating organ-specific involvement
Time frame: The pre- and post-transplant serum samples,capillaroscopic and fibroelastographic examinations will be performed for each participant at the specified time interval until post-transplant 100th day
The effectiveness of biomarkers in predicting the development of GVHD, transplant-related endothelial injury, and non-relapse mortality
Time frame: The pre- and post-transplant serum samples,capillaroscopic and fibroelastographic examinations will be performed for each participant at the specified time interval until post-transplant 100th day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Meltem Kurt Yüksel study director
Ankara University, Department of Hematology
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 Acute Myeloid Leukemia, Adult and Graft Versus Host Disease, run by Ugur Arzu Kulu at 1 site in Turkey (Türkiye).
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 3 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: withdrawn, as of the sponsor's last update on 29 Jan 2025. 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 Turkey (Türkiye). 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 was withdrawn before enrolling participants, so there are no results.
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?
The relationship between pyroptosis, GVHD and endothelial damage in allogeneic bone marrow transplant patients (time frame: The pre- and post-transplant serum samples,capillaroscopic and fibroelastographic examinations will be performed for each participant at the specified time interval until post-transplant 100th day). 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 29 Jan 2025.