IBA_ECP: Intestinal Biomarker Analysis After ECP for ICI Colitis

Sponsor

University of Freiburg (Other)

Overall Status

Recruiting

CT.gov ID

NCT06074874

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colitis Immune Checkpoint Inhibitor-Related Colitis	Other: Intestinal tissue analysis

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

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Intestinal Biomarker Analysis After ECP for ICI Colitis

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Outcome Measures

Primary Outcome Measures

T cell number and phenotype measurement in the intestinal tract [6 months]
Analysis of CD3+ T cells by flow cytometry

Secondary Outcome Measures

T cell number measurement by immunohistochemistry [6 months]
Analysis of CD3+ T cells by immunohistochemistry
Analysis of arginase amounts in the intestinal tract using qPCR [6 months]
Analysis of arginase mRNA expression by realtime PCR (qRT-PCR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

ICI colitis

Exclusion Criteria:

no informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Freiburg University Medical Center	Freiburg	Baden Württemberg	Germany	79106

Sponsors and Collaborators

University of Freiburg

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Robert Zeiser, Director Division of Tumor immunology, University of Freiburg

ClinicalTrials.gov Identifier:

NCT06074874

Other Study ID Numbers:

ICI_colitis_ECP

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Study Results

No Results Posted as of Oct 10, 2023