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Recruiting NCT04030676

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

No phase Interventional Cytomegalovirus Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsies, Blood samples.
Who it may be relevant to
Registry conditions: Cytomegalovirus Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)

Overview

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.

Interventions

  • Procedure Biopsies
    Two more biopsies in inflammatory zone will be collected.
  • Biological Blood samples
    Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.

Primary outcome measures

  • Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells [Time frame: At the inclusion]
  • QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood [Time frame: At the inclusion]
Secondary outcome measures (3)
  • Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue [Time frame: At the inclusion]
  • Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) [Time frame: At the inclusion]
  • QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood [Time frame: At 14 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 2 centers
  • HCL-Hôpital Lyon Sud — Lyon
  • Chu Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT04030676 · 18CH053 · 2018-A01622-53

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗