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

Cytomegalovirus Infections Clinical Trial

— RECOHFERRON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030676
• Other study ID #: 18CH053
• Secondary ID: 2018-A01622-53
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Xavier ROBLIN, MD PhD
• Phone: (0)477828119
• Email: xavier.roblin[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: April 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Cytomegalovirus Infections
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
France	HCL-Hôpital Lyon Sud	Lyon
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the inclusion
Primary	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.	At the inclusion
Secondary	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.	At the inclusion
Secondary	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.	At the inclusion
Secondary	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.	At 14 weeks