Cellular Stress Reactions During Graft-versus-host Disease

Sponsor
University of Freiburg (Other)
Overall Status
Recruiting
CT.gov ID
NCT04558788
Collaborator
(none)
40
1
38
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Immunohistochemistry on intestinal biopsies

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Analysis of Cellular Stress Markers in the Intestine of Patients With Graft-versus-host Disease
Actual Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Uninflamed intestine

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

Diagnostic Test: Immunohistochemistry on intestinal biopsies
Immunohistochemistry will be performed on human intestinal biopsies

Colitis

Patients with active colitis

Diagnostic Test: Immunohistochemistry on intestinal biopsies
Immunohistochemistry will be performed on human intestinal biopsies

Acute GVHD

Patients with acute gastrointestinal (GI) GVHD

Diagnostic Test: Immunohistochemistry on intestinal biopsies
Immunohistochemistry will be performed on human intestinal biopsies

Outcome Measures

Primary Outcome Measures

  1. Immunohistochemical staining [1 year]

    Immunohistochemical staining

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical Center University of Freiburg Freiburg Baden-Württemberg Germany 79106

Sponsors and Collaborators

  • University of Freiburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert Zeiser, Director of the Division of Tumor Immunology, University of Freiburg
ClinicalTrials.gov Identifier:
NCT04558788
Other Study ID Numbers:
  • Cellular stress in GVHD
First Posted:
Sep 22, 2020
Last Update Posted:
Sep 22, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2020