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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04030676

Collaborator

(none)

196

Enrollment

Locations

Arm

56.5

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Infections	Procedure: Biopsies Biological: Blood samples	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

196 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 17, 2019

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QuantiFERON Test Patient with CytoMegaloVirus (CMV) infection will be included. They will have biopsies and blood samples, composite of QuantiFERON-CytoMegaloVirus (QF-CMV) assay.	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.

Arm

Intervention/Treatment

Experimental: QuantiFERON Test

Patient with CytoMegaloVirus (CMV) infection will be included. They will have biopsies and blood samples, composite of QuantiFERON-CytoMegaloVirus (QF-CMV) assay.

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.

Outcome Measures

Primary Outcome Measures

Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells [At the inclusion]
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.
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood [At the inclusion]
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.

Secondary Outcome Measures

Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue [At the inclusion]
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.
Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) [At the inclusion]
To evaluate the concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) analysis.
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood [At 14 weeks]
To compare measure of the QuantiFERON-CytoMegaloVirus (QF-CMV) assay at the flare-up and 14 weeks after.