ACE-UC: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis

Sponsor

Asan Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02439372

Collaborator

(none)

Enrollment

Location

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. Theoretically, CMV-specific cell-mediate immune response will further categorize the patients into high or low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV colitis on ulcerative colitis flare.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Cytomegalovirus Infections Disease Exacerbation

Detailed Description

Moderate to severe ulcerative colitis patients admitted in Inflammatory Bowel Disease (IBD) center will be enrolled in this study. Eligible patients had active UC with a Mayo score of 6-12 points (moderate or severe disease activity). The investigators will evaluate whether CMV-specific cell-mediated immune response at admission will predict the risk of active cytomegalovirus infection (true pathogen versus bystander).

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis (ACE-UC)

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Outcome Measures

Primary Outcome Measures

CMV infection [participants will be followed for the duration of hospital stay, an expected average of 2 weeks]
CMV colitis (CMV disease involving the colon) was diagnosed by colonic tissue polymerase chain reaction (PCR) or immunohistochemistry (IHC) in accordance with current European guidelines

Secondary Outcome Measures

Viral clearance from colonic mucosa [participants will be followed for the duration of hospital stay, an expected average of 2 weeks]
Viral clearance from colonic mucosa was diagnosed as negative by immunohistochemistry (IHC) after a ganciclovir treatment
Breakthrough CMV infection [participants will be followed for the duration of hospital stay, an expected average of 2 weeks]
Breakthrough CMV colitis was diagnosed by newly positive colonic tissue polymerase chain reaction (PCR) or immunohistochemistry (IHC) at the time of second colonic biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

moderate to severe UC require hospitalization
age 16 or more
agree with written informed consent

Exclusion Criteria:

pregnancy
foreign
immunosuppressed patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	138-736

Sponsors and Collaborators

Asan Medical Center

Investigators

Principal Investigator: Sung-Han Kim, MD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sung-Han Kim, Associate Professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT02439372

Other Study ID Numbers:

Report Number 2015-0129

First Posted:

May 8, 2015

Last Update Posted:

Jan 18, 2020

Last Verified:

Jan 1, 2020

Additional relevant MeSH terms:

Cytomegalovirus Infections

Study Results

No Results Posted as of Jan 18, 2020