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

NCT06200441 | Withdrawn

• 1 other identifier: AnkaraUniversityMedicine
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy of used GVHD biomarkers in indicating organ-specific involvement

  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 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ugur Arzu Kulu: lead

Study Sites (1)

Ankara University, Department of Hematology

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Meltem Kurt Yüksel

  Ankara University, Department of Hematology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 11, 2024
• Study Start: November 15, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)