Graft Vs Host DiseaseNCT04558788
Cellular Stress Reactions During Graft-versus-host Disease
An observational study of Graft Vs Host Disease and Graft Versus Host Disease, run by University of Freiburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Graft Vs Host Disease, Graft Versus Host Disease
- What is being tested?
- Immunohistochemistry on intestinal biopsies
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age >18 years intestinal biopsy depending on cohort: healthy intestinal tissue, colitis or GVHD
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Center University of Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
Official title: Analysis of Cellular Stress Markers in the Intestine of Patients With 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.
Read the 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.
- Conditions
- Graft Vs Host Disease, Graft Versus Host Disease
- Being tested
- Immunohistochemistry on intestinal biopsies
- Keywords
- GVHD
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry on intestinal biopsiesDiagnostic test
Immunohistochemistry will be performed on human intestinal biopsies
| Study group | Role | What they receive |
|---|---|---|
| Uninflamed intestine | Patients who underwent diagnostic endoscopy and received a diagnosis of no intestinal inflammation Receives: Diagnostic Test: Immunohistochemistry on intestinal biopsies | |
| Colitis | Patients with active colitis Receives: Diagnostic Test: Immunohistochemistry on intestinal biopsies | |
| Acute GVHD | Patients with acute gastrointestinal (GI) GVHD Receives: Diagnostic Test: Immunohistochemistry on intestinal biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemical staining
Immunohistochemical staining
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Nov 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Zeiser, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558788
- Sponsor's protocol ID
- Cellular stress in GVHD
- Status last verified
- Nov 2023
- First submitted
- 16 Sep 2020
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cellular Stress Markers in the Intestine of Patients With Graft-versus-host Disease
- ClinicalTrials.gov ID
- NCT04558788
- Acronym / sponsor ID
- Cellular stress in GVHD
- Conditions
- Graft Vs Host Disease, Graft Versus Host Disease
- Keywords
- GVHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Uninflamed intestine | – | Diagnostic Test: Immunohistochemistry on intestinal biopsiesPatients who underwent diagnostic endoscopy and received a diagnosis of no intestinal inflammation |
| Colitis | – | Diagnostic Test: Immunohistochemistry on intestinal biopsiesPatients with active colitis |
| Acute GVHD | – | Diagnostic Test: Immunohistochemistry on intestinal biopsiesPatients with acute gastrointestinal (GI) GVHD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age >18 years intestinal biopsy depending on cohort: healthy intestinal tissue, colitis or GVHD
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemistry on intestinal biopsiesImmunohistochemistry will be performed on human intestinal biopsies | Diagnostic test | Acute GVHD, Colitis, Uninflamed intestine |
Primary outcome
Immunohistochemical staining
Time frame: 1 year
Immunohistochemical staining
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft Vs Host Disease and Graft Versus Host Disease, run by University of Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemical staining (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.