Clinical trial NCT04030676: QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis
Official title: Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cytomegalovirus Infections
Keywords: Immune response against
QuantiFERON-CytoMegaloVirus (QF-CMV)
Ulcerative Colitis (UC)
CytoMegaloVirus (CMV)
quantitative PolymeraseChainReaction (qPCR)
ImmunoHistoChemistry (IHC)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells
timeFrame: At the inclusion
measure: QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood
timeFrame: At the inclusion
Secondary outcomes:
measure: Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue
timeFrame: At the inclusion
measure: Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC)
timeFrame: At the inclusion
measure: QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood
timeFrame: At 14 weeks
Other outcomes:
Locations:
city: Lyon
country: France
facility: HCL-Hôpital Lyon Sud
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Xavier ROBLIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU SAINT-ETIENNE
name: Sylvie PILLET, PhD
role: STUDY_DIRECTOR
References: