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Completed

NCT Number: NCT04558788

Cellular Stress Reactions During Graft-versus-host Disease

This study has the aim to analyze intestinal expression of cellular stress molecules in patients with intestinal GVHD. Patients with colitis and patients without intestinal inflammation will serve as controls.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

About this study

Acute graft-versus-host disease (GVHD) is a major cause of morbidity and mortality in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT). Acute GVHD results from a complex multi-step crosstalk between extensive epithelial tissue damage in the patient and activation of the allo-reactive immune system transferred with the donor graft. The conditioning treatment prior to allo-HCT creates an inflamed microenvironment with high concentrations of pathogen-associated and danger-associated molecular patterns (PAMPs and DAMPs) as well as pro-inflammatory cytokines. This inflammation is perpetuated by activation of myeloid immune cells and recruitment of allo-reactive T cells to the intestine. Enterocytes are subjected to cellular stress and undergo apoptosis. As a result, patients can develop high-voluminous diarrhea, dehydration, intestinal bleeding, hypalbuminemia, and generalized infections.

In this study, the investigators aim to analyze the expression of molecules related to different types of cellular stress in the intestine of patients with acute GVHD. The hypothesis is that some stress-related markers would be upregulated during GVHD. The results will be valuable to study the role of cellular stress reactions during acute GVHD pathogenesis or as potential biomarkers for disease activity.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >18 years intestinal biopsy depending on cohort: healthy intestinal tissue, colitis or GVHD

Treatment and study plan

Immunohistochemistry on intestinal biopsies

Diagnostic Test

Immunohistochemistry will be performed on human intestinal biopsies

Primary outcomes

  1. Immunohistochemical staining

    Time frame: 1 year

    Immunohistochemical staining

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Official study title

Analysis of Cellular Stress Markers in the Intestine of Patients With Graft-versus-host Disease

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2020
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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