Clinical trial NCT06200441: Correlation of Serum Gasdermin-D and NLRP-3 Inflammasome Levels With GVHD Biomarkers and Endothelial Damage Markers in Graft-Versus-Host Disease
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Myeloid Leukemia, Adult
Graft Versus Host Disease
Endothelial Dysfunction
Keywords: Acute Myeloid Leukemia, Adult
Graft Versus Host Disease
Pyroptotic Cell Death
Gasdermin-D
NLR Family, Pyrin Domain-Containing 3 Protein
Endothelial Dysfunction
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The relationship between pyroptosis, GVHD and endothelial damage in allogeneic bone marrow transplant patients
timeFrame: 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:
measure: Efficacy of used GVHD biomarkers in indicating organ-specific involvement
timeFrame: 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
measure: The effectiveness of biomarkers in predicting the development of GVHD, transplant-related endothelial injury, and non-relapse mortality
timeFrame: 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
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University, Department of Hematology
Study officials:
affiliation: Ankara University, Department of Hematology
name: Meltem Kurt Yüksel
role: STUDY_DIRECTOR
References: