NCT04558788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

3.2 years

First QC Date

September 16, 2020

Last Update Submit

November 28, 2023

Conditions

Graft Vs Host DiseaseGraft Versus Host Disease

Keywords

GVHD

Outcome Measures

Primary Outcomes (1)

  • Immunohistochemical staining

    Immunohistochemical staining

    1 year

Study Arms (3)

Uninflamed intestine

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

Diagnostic Test: Immunohistochemistry on intestinal biopsies

Colitis

Patients with active colitis

Diagnostic Test: Immunohistochemistry on intestinal biopsies

Acute GVHD

Patients with acute gastrointestinal (GI) GVHD

Diagnostic Test: Immunohistochemistry on intestinal biopsies

Interventions

Immunohistochemistry on intestinal biopsiesDIAGNOSTIC_TEST

Immunohistochemistry will be performed on human intestinal biopsies

Acute GVHDColitisUninflamed intestine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will recruit adults at least 18 years of age, who underwent intestinal biopsy and either had (i) non-inflamed intestinal tissue, (ii) colitis, (iii) graft-versus-host disease.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Division of Tumor Immunology

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

November 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 5, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)