NCT06074874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

September 28, 2023

Last Update Submit

April 2, 2024

Conditions

ColitisImmune Checkpoint Inhibitor-Related Colitis

Outcome Measures

Primary Outcomes (1)

  • T cell number and phenotype measurement in the intestinal tract

    Analysis of CD3+ T cells by flow cytometry

    6 months

Secondary Outcomes (2)

  • T cell number measurement by immunohistochemistry

    6 months

  • Analysis of arginase amounts in the intestinal tract using qPCR

    6 months

Interventions

Intestinal tissue analysisOTHER

Intestinal tissue analysis

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ICI colitis

You may qualify if:

  • ICI colitis

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freiburg University Medical Center

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (2)

  • 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.

    PMID: 31940706RESULT

  • 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.

    PMID: 33203951RESULT

Biospecimen

Retention: SAMPLES WITH DNA

intestinal biopsies and peripheral blood samples

MeSH Terms

Conditions

Colitis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Division of Tumor immunology

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 10, 2023

Study Start

July 1, 2023

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)