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Cellular Stress Reactions During Graft-versus-host Disease

U

University of Freiburg

Status

Completed

Conditions

Graft Vs Host Disease
Graft Versus Host Disease

Treatments

Diagnostic Test: Immunohistochemistry on intestinal biopsies

Study type

Observational

Funder types

Other

Identifiers

NCT04558788
Cellular stress in GVHD

Details and patient eligibility

About

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.

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

40 participants in 3 patient groups

Uninflamed intestine
Description:
Patients who underwent diagnostic endoscopy and received a diagnosis of no intestinal inflammation
Treatment:
Diagnostic Test: Immunohistochemistry on intestinal biopsies
Colitis
Description:
Patients with active colitis
Treatment:
Diagnostic Test: Immunohistochemistry on intestinal biopsies
Acute GVHD
Description:
Patients with acute gastrointestinal (GI) GVHD
Treatment:
Diagnostic Test: Immunohistochemistry on intestinal biopsies

Trial contacts and locations

1

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Central trial contact

Robert Zeiser, MD; Petya Apostolova, MD

Data sourced from clinicaltrials.gov

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