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NCT06074874 Clinical Trial

Intestinal Biomarker Analysis After ECP for ICI Colitis

Colitis Clinical Trial

— IBA_ECP  

Official title:
Intestinal Biomarker Analysis After ECP for ICI Colitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06074874
Other study ID # ICI_colitis_ECP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date March 30, 2024

Study information
Verified date April 2024
Source University of Freiburg
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ICI colitis Exclusion Criteria: - no informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Intestinal tissue analysis
Intestinal tissue analysis

Locations
Country Name City State
Germany Freiburg University Medical Center Freiburg Baden Württemberg

Sponsors (1)
Lead Sponsor Collaborator
University of Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Maas-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- — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary T cell number and phenotype measurement in the intestinal tract Analysis of CD3+ T cells by flow cytometry 6 months
Secondary T cell number measurement by immunohistochemistry Analysis of CD3+ T cells by immunohistochemistry 6 months
Secondary Analysis of arginase amounts in the intestinal tract using qPCR Analysis of arginase mRNA expression by realtime PCR (qRT-PCR) 6 months
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