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

Last updated: April 28, 2025
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Cytomegalovirus Infections

Crohn's Disease

Treatment

Biopsies

Blood samples

Clinical Study ID

NCT04030676
18CH053
2018-A01622-53
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with seropositive for CytoMegaloVirus (CMV) (IgG+)

  • Patient requiring hospitalization for flare of Ulcerative Colitis (UC) with Mayoscore > 5 and an endoscopic subscore ≥ 2

  • Social security affiliation

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Wardship patient and curatorial patient

  • Patient unable to understand or sign the protocol

  • Colectomy total or partial

Study Design

Total Participants: 196
Treatment Group(s): 2
Primary Treatment: Biopsies
Phase:
Study Start date:
July 17, 2019
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • HCL-Hôpital Lyon Sud

    Lyon,
    France

    Active - Recruiting

  • Chu Saint-Etienne

    Saint-Étienne,
    France

    Active - Recruiting

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