QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis

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

RECRUITING

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2026-04-30

Brief Summary

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CytoMegaloVirus (CMV) infection impairs evolution of Ulcerative Colitis (UC) leading to more severe and resistant to immunosuppressive therapies flare-up. CytoMegaloVirus (CMV) reactivation is assessed by the quantification of the CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load by real-time PCR (qPCR) in colonic biopsies; this assay is invasive and costly. The QuantiFERON-CytoMegaloVirus (QF-CMV) assay measures the immune response against CytoMegaloVirus (CMV) in a blood specimen.

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Detailed Description

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This study aim to evaluate the performances of this new assay to predict the risk of CytoMegaloVirus (CMV) reactivation in the colon of UC patients. A new algorithm for the care of Ulcerative Colitis (UC) patients that could be used in all centers, even those without molecular biology lab, could be proposed: in case of a positive QuantiFERON-CytoMegaloVirus (QF-CMV) assay, the immune response protects the patient against Cytomegalovirus (CMV) reactivation and intensification of immunosuppressive therapies should be proposed; at the opposite, a negative QuantiFERON-CytoMegaloVirus (QF-CMV) assay will invite to biopsy in order to detect CytoMegaloVirus (CMV) replication and to treat with ganciclovir when appropriate. This algorithm will preserve invasive biopsies in absence of CytoMegaloVirus (CMV) tissue reactivation.

Conditions

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Cytomegalovirus Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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QuantiFERON Test

Patient with CytoMegaloVirus (CMV) infection will be included. They will have biopsies and blood samples, composite of QuantiFERON-CytoMegaloVirus (QF-CMV) assay.

Group Type EXPERIMENTAL

Biopsies

Intervention Type PROCEDURE

Two more biopsies in inflammatory zone will be collected.

Blood samples

Intervention Type BIOLOGICAL

Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.

Interventions

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Biopsies

Two more biopsies in inflammatory zone will be collected.

Intervention Type PROCEDURE

Blood samples

Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patient with seropositive for CytoMegaloVirus (CMV) (IgG+)
* Patient requiring hospitalization for flare of Ulcerative Colitis (UC) with Mayo score \> 5 and an endoscopic subscore ≥ 2
* Social security affiliation
* Signed informed consent