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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    196
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 1 May 2022
immunosuppressive agents
immunosuppression
colitis

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.

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.

Details
Condition Cytomegalovirus Infections
Treatment blood samples, Biopsies
Clinical Study IdentifierNCT04030676
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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