Intestinal Biomarker Analysis After ECP for ICI Colitis

NCT ID: NCT06074874

Last Updated: 2024-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-03-30

Brief Summary

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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

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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.

Conditions

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Colitis Immune Checkpoint Inhibitor-Related Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Intestinal tissue analysis

Intestinal tissue analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ICI colitis

Exclusion Criteria

* no informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Freiburg

OTHER

Sponsor Role lead

Responsible Party

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Robert Zeiser

Director Division of Tumor immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Freiburg University Medical Center

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 31940706 (View on PubMed)

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/s41409-020-01122-8. Epub 2020 Nov 17.

Reference Type RESULT
PMID: 33203951 (View on PubMed)

Other Identifiers

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ICI_colitis_ECP

Identifier Type: -

Identifier Source: org_study_id

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