ColitisIBA_ECPNCT06074874
Intestinal Biomarker Analysis After ECP for ICI Colitis
An observational study of Colitis and Immune Checkpoint Inhibitor-Related Colitis, run by University of Freiburg at 1 site in Germany.
Trial summary
It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the chnages of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colitis, Immune Checkpoint Inhibitor-Related Colitis
- What is being tested?
- Intestinal tissue analysis
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2023to 30 Mar 2024
- 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
- Adult, Older adult
Study population: Patients with ICI colitis
Who may be able to join
- ICI colitis
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Freiburg University Medical Center
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the chnages of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.
Read the detailed description
It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the changes of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.
- Being tested
- Intestinal tissue analysis
- Medical subject headings
- Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal tissue analysisOther
Intestinal tissue analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell number and phenotype measurement in the intestinal tract
Analysis of CD3+ T cells by flow cytometry
Measured: 6 months
Secondary outcomes (2)
T cell number measurement by immunohistochemistry
Analysis of CD3+ T cells by immunohistochemistry
Measured: 6 months
Analysis of arginase amounts in the intestinal tract using qPCR
Analysis of arginase mRNA expression by realtime PCR (qRT-PCR)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jul 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ColitisStudies 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
- 20 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
- NCT06074874
- Sponsor's protocol ID
- ICI_colitis_ECP
- Acronym
- IBA_ECP
- Status last verified
- Apr 2024
- First submitted
- 28 Sep 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apostolova P, Unger S, von Bubnoff D, Meiss F, Becher B, Zeiser R. Extracorporeal Photopheresis for Colitis Induced by Checkpoint-Inhibitor Therapy. N Engl J Med. 2020 Jan 16;382(3):294-296. doi: 10.1056/NEJMc1912274. No abstract available.
PubMed 31940706Maas-Bauer K, Kiote-Schmidt C, Bertz H, Apostolova P, Wasch R, Ihorst G, Finke J, Zeiser R. Ruxolitinib-ECP combination treatment for refractory severe chronic graft-versus-host disease. Bone Marrow Transplant. 2021 Apr;56(4):909-916. doi: 10.1038/s41409-020-01122-8. Epub 2020 Nov 17.
PubMed 33203951
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Biomarker Analysis After ECP for ICI Colitis
- ClinicalTrials.gov ID
- NCT06074874
- Acronym / sponsor ID
- IBA_ECP / ICI_colitis_ECP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FreiburgUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 10 Oct 2023 (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.
It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the chnages of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.
Detailed description
It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the changes of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with ICI colitis
Key inclusion criteria (1 listed)
- ICI colitis
Key exclusion criteria (1 listed)
- no informed consent
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 |
|---|---|---|
| Intestinal tissue analysisIntestinal tissue analysis | Other | – |
Primary outcome
T cell number and phenotype measurement in the intestinal tract
Time frame: 6 months
Analysis of CD3+ T cells by flow cytometry
2 secondary outcomes
T cell number measurement by immunohistochemistry
Time frame: 6 months
Analysis of arginase amounts in the intestinal tract using qPCR
Time frame: 6 months
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 3 Apr 2024.
- Results publication: PubMed 31940706Apostolova P, Unger S, von Bubnoff D, Meiss F, Becher B, Zeiser R. Extracorporeal Photopheresis for Colitis Induced by Checkpoint-Inhibitor Therapy. N Engl J Med. 2020 Jan 16;382(3):294-296. doi: 10.1056/NEJMc1912274. No abstract available.
- Results publication: PubMed 33203951Maas-Bauer K, Kiote-Schmidt C, Bertz H, Apostolova P, Wasch R, Ihorst G, Finke J, Zeiser R. Ruxolitinib-ECP combination treatment for refractory severe chronic graft-versus-host disease. Bone Marrow Transplant. 2021 Apr;56(4):909-916. doi: 10.1038/s41409-020-01122-8. Epub 2020 Nov 17.
- Individual participant dataSharing planned: No
Related trials for Colitis
RecruitingPhase 2
Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation
Ulcerative Colitis, Ileal Pouch
RecruitingEarly Phase 1
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
Clostridioides Difficile Infection
RecruitingPhase 1/2
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Active, not recruitingPhase 2
A Study to Investigate the Efficacy and Safety of Brivekimig in Adult Participants With Ulcerative Colitis
Ulcerative Colitis
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 Colitis and Immune Checkpoint Inhibitor-Related Colitis, 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 1 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 3 Apr 2024. 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?
T cell number and phenotype measurement in the intestinal tract (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074874, which also lists 2 linked publications.
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 3 Apr 2024.