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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Wardship patient and curatorial patient

Patient unable to understand or sign the protocol

Colectomy total or partial

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsies

    Procedure/Surgery

    Two more biopsies in inflammatory zone will be collected.

  • Blood samples

    Biological/Vaccine

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

Treatment groups

196 Participants
are divided into 1 treatment group
Group A: QuantiFERON TestExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells

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.

Time frame
At the inclusion
2

QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood

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.

Time frame
At the inclusion

Secondary outcomes

1

Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue

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.

Time frame
At the inclusion
2

Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC)

To evaluate the concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) analysis.

Time frame
At the inclusion
3

QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood

To compare measure of the QuantiFERON-CytoMegaloVirus (QF-CMV) assay at the flare-up and 14 weeks after.

Time frame
At 14 weeks

Other outcomes

Sponsors and contacts

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