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Intestinal Biomarker Analysis After ECP for ICI Colitis

Completed
Conditions
Colitis
Immune Checkpoint Inhibitor-Related Colitis
Registration Number
NCT06074874
Lead Sponsor
University of Freiburg
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • ICI colitis
Exclusion Criteria
  • no informed consent

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
T cell number and phenotype measurement in the intestinal tract6 months

Analysis of CD3+ T cells by flow cytometry

Secondary Outcome Measures
NameTimeMethod
T cell number measurement by immunohistochemistry6 months

Analysis of CD3+ T cells by immunohistochemistry

Analysis of arginase amounts in the intestinal tract using qPCR6 months

Analysis of arginase mRNA expression by realtime PCR (qRT-PCR)

Trial Locations

Locations (1)

Freiburg University Medical Center

🇩🇪

Freiburg, Baden Württemberg, Germany

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