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

Not Applicable

Recruiting

• Conditions: Cytomegalovirus Infections
• Interventions: Procedure: Biopsies; Biological: Blood samples

• Registration Number: NCT04030676
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-07-17
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-01
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 196

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

Exclusion Criteria

• Wardship patient and curatorial patient
• Patient unable to understand or sign the protocol
• Colectomy total or partial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells	At the inclusion	Theses two primary outcomes will determinate the sensibility, specificity, positive predictive value and negative predictive value of the QF-CMV in prediction CMV reactivation in Ulcerative Colitis (UC) patients with acute flare-up.
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood	At the inclusion	Theses two primary outcomes will determinate the sensibility, specificity, positive predictive value and negative predictive value of the QF-CMV in prediction CMV reactivation in Ulcerative Colitis (UC) patients with acute flare-up.

Secondary Outcome Measures

Name	Time	Method
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood	At 14 weeks	To compare measure of the QuantiFERON-CytoMegaloVirus (QF-CMV) assay at the flare-up and 14 weeks after.
Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue	At the inclusion	To determine the performance threshold of the QuantiFERON-CytoMegaloVirus (QF-CMV) assay as assessed by ImmunoHistoChemistry (IHC) that can predict CytoMegaloVirus (CMV) reactivation in colonic biopsies in Ulcerative Colitis (UC) patients with acute flare-up.
Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC)	At the inclusion	To evaluate the concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) analysis.

Trial Locations

Locations (2)

HCL-Hôpital Lyon Sud; 🇫🇷 Lyon, France

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France