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Intestinal Biomarker Analysis After ECP for ICI Colitis

Intestinal Biomarker Analysis After ECP for ICI Colitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06074874
Acronym
IBA_ECP
Enrollment
20
Registered
2023-10-10
Start date
2023-07-01
Completion date
2024-03-30
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Immune Checkpoint Inhibitor-Related Colitis

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.

Interventions

OTHERIntestinal tissue analysis

Intestinal tissue analysis

Sponsors

University of Freiburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* ICI colitis

Exclusion criteria

* no informed consent

Design outcomes

Primary

MeasureTime frameDescription
T cell number and phenotype measurement in the intestinal tract6 monthsAnalysis of CD3+ T cells by flow cytometry

Secondary

MeasureTime frameDescription
T cell number measurement by immunohistochemistry6 monthsAnalysis of CD3+ T cells by immunohistochemistry
Analysis of arginase amounts in the intestinal tract using qPCR6 monthsAnalysis of arginase mRNA expression by realtime PCR (qRT-PCR)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026