Correlation of Serum Gasdermin-D and NLRP-3 Inflammasome Levels With GVHD Biomarkers and Endothelial Damage Markers in Graft-Versus-Host Disease

Endothelial Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06200441
• Other study ID #: AnkaraUniversityMedicine
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: January 2024
• Source: Ankara University
• Contact: Ugur Arzu Kulu
• Phone: +90 05320567509
• Email: arzu.kulu[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Adult
• Endothelial Dysfunction
• Graft Versus Host Disease
• Graft vs Host Disease
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Turkey	Ankara University, Department of Hematology	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ugur Arzu Kulu

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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	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