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

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ClinicalTrials.gov Identifier: NCT02439372
Recruitment Status : Unknown
Verified May 2015 by Sung-Han Kim, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center

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
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).

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Study Type : Observational
Estimated 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 : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016





Primary Outcome Measures :
  1. CMV infection [ Time Frame: 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 :
  1. Viral clearance from colonic mucosa [ Time Frame: 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

  2. Breakthrough CMV infection [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Moderate to severe ulcerative colitis (Eligible patients had active UC with a Mayo score of 6-12 points)
Criteria

Inclusion Criteria:

  • moderate to severe UC require hospitalization
  • age 18 or more
  • agree with written informed consent

Exclusion Criteria:

  • pregnancy
  • foreign
  • immunosuppressed patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439372


Contacts
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Contact: Sung-Han Kim, MD 82-2-3010-3305 kimsunghanmd@hotmail.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sung-Han Kim, MD    82-2-3010-3305    kimsunghanmd@hotmail.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Sung-Han Kim, MD Asan Medical Center

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Responsible Party: Sung-Han Kim, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02439372     History of Changes
Other Study ID Numbers: Report Number 2015-0129
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Cytomegalovirus Infections
Colitis
Ulcer
Colitis, Ulcerative
Disease Progression
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Disease Attributes