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

NCT04030676 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Phase

Not applicable

Started

2019-07-17

Last updated

2025-04-29

Condition(s) studied

Cytomegalovirus Infections

Investigational drug(s) / intervention(s)

BiopsiesBlood samples →

Biopsies: Two more biopsies in inflammatory zone will be collected.

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

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.

Trial sites (2)

Facility	City	Region	Status
HCL-Hôpital Lyon Sud	Lyon	France	Recruiting
Chu Saint-Etienne	Saint-Etienne	France	Recruiting

More Centre Hospitalier Universitaire de Saint Etienne trials in France

Purine Supplementation in Patients With AICA-Ribosiduria Recruiting

Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness Recruiting

Evaluation of the Elasticity of the Mitral Valve Recruiting

Project MILANO: Connections Between Patients With Brain Tumors and Their Pets: an Analysis of Concerns and Needs Recruiting

Objective Assessment of Skin Damage Using ADHELASKIN in Patients With Systemic Sclerosis Recruiting

Other trials for the same condition

Casting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation Active, not recruiting

Ganciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients Recruiting

Evaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals Recruiting

Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04030676 on ClinicalTrials.gov ↗ ← All trials in France