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Cellular Stress Reactions During Graft-versus-host Disease

NCT ID: NCT04558788

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Graft Vs Host Disease Graft Versus Host Disease

Keywords

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GVHD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Uninflamed intestine

Patients who underwent diagnostic endoscopy and received a diagnosis of no intestinal inflammation

Immunohistochemistry on intestinal biopsies

Intervention Type DIAGNOSTIC_TEST

Immunohistochemistry will be performed on human intestinal biopsies

Colitis

Patients with active colitis

Immunohistochemistry on intestinal biopsies

Intervention Type DIAGNOSTIC_TEST

Immunohistochemistry will be performed on human intestinal biopsies

Acute GVHD

Patients with acute gastrointestinal (GI) GVHD

Immunohistochemistry on intestinal biopsies

Intervention Type DIAGNOSTIC_TEST

Immunohistochemistry will be performed on human intestinal biopsies

Interventions

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Immunohistochemistry on intestinal biopsies

Immunohistochemistry will be performed on human intestinal biopsies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Freiburg

OTHER

Sponsor Role lead

Responsible Party

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Robert Zeiser

Director of the Division of Tumor Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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Cellular stress in GVHD

Identifier Type: -

Identifier Source: org_study_id