RECRUITING

Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this observational study is to learn about the mechanism of action of ozanimod in patients with ulcerative colitis (UC). The main questions it aims to answer are: 1. Prospectively assess the effects of ozanimod on the cellular composition of intestinal lamina propria and blood by deep immunophenotyping (CyTOF) of immune cell subsets prior and after the drug's administration. 2. Determine whether changes in cell subsets observed via mass cytometry correlate with with clinical or histologic parameters of disease activity. Colonic biopsies and peripheral blood samples will be collected from patients with UC before and after the onset of ozanimod. Researchers will compare intestinal and peripheral leukocytes before and after the drug's administration.

Official Title

High Dimensional Mass Cytometry as a Tool to Understand Ozanimod's Mechanism of Action (MOA)

Quick Facts

Study Start:2023-10-06
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06311123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female patients aged 18 or older.
  2. 2. Have had UC diagnosed at least 3 months prior to screening. The diagnosis must be confirmed by endoscopic and histologic evidence.
  3. 3. Have active UC confirmed on endoscopy.
  4. 4. Ability to provide written informed consent to IBD biobank (UCSD)
  5. 5. Patients with above criteria being considered for ozanimod therapy and will not be treated in conjunction with biologics.
  1. 1. Have severe IBD as evidenced by:physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline
  2. 2. Current evidence of fulminant colitis, toxic megacolon or bowel perforation
  3. 3. Previous total colectomy
  4. 4. Platelet count\<100,000/μL
  5. 5. Have positive stool culture for pathogens (O+P, bacteria) or positive test for C. difficile at screening. If C. difficile is positive, the patient may be treated and retested.
  6. 6. Prisoners or subjects involuntarily detained will not be included.

Contacts and Locations

Study Contact

Jesus Rivera-Nieves, MD
CONTACT
8585345495
jriveran@ucsd.edu
Alyssa Blair
CONTACT
858-822-4939

Study Locations (Sites)

University of California San Diego
San Diego, California, 92093-006
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-06
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-10-06
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • colitis
  • ozanimod
  • mass cytometry

Additional Relevant MeSH Terms

  • Ulcerative Colitis
  • Ulcerative Colitis Chronic Moderate