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OpenTrials
Completed

NCT Number: NCT06074874

Intestinal Biomarker Analysis After ECP for ICI Colitis

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.

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Key information

Conditions

Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Immune Checkpoint Inhibitor-Related Colitis Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Freiburg University Medical Center

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICI colitis

Exclusion criteria

  • no informed consent

Treatment and study plan

Intestinal tissue analysis

Other

Intestinal tissue analysis

Primary outcomes

  1. T cell number and phenotype measurement in the intestinal tract

    Time frame: 6 months

    Analysis of CD3+ T cells by flow cytometry

Secondary outcomes

  1. T cell number measurement by immunohistochemistry

    Time frame: 6 months

    Analysis of CD3+ T cells by immunohistochemistry

  2. Analysis of arginase amounts in the intestinal tract using qPCR

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Freiburg

Other

Registry information

Acronym: IBA_ECP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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