NCT04030676

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

6.5 years

First QC Date

July 19, 2019

Last Update Submit

April 28, 2025

Conditions

Cytomegalovirus Infections

Keywords

Immune response againstQuantiFERON-CytoMegaloVirus (QF-CMV)Ulcerative Colitis (UC)CytoMegaloVirus (CMV)quantitative PolymeraseChainReaction (qPCR)ImmunoHistoChemistry (IHC)

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue

    At the inclusion

  • Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC)

    At the inclusion

  • QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood

    At 14 weeks

Study Arms (1)

QuantiFERON Test

EXPERIMENTAL

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

Procedure: BiopsiesBiological: Blood samples

Interventions

BiopsiesPROCEDURE

Two more biopsies in inflammatory zone will be collected.

QuantiFERON Test
Blood samplesBIOLOGICAL

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

QuantiFERON Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Wardship patient and curatorial patient
  • Patient unable to understand or sign the protocol
  • Colectomy total or partial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HCL-Hôpital Lyon Sud

Lyon, France

RECRUITING

Chu Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus InfectionsColitis, Ulcerative

Interventions

BiopsyBlood Specimen Collection

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesPunctures

Study Officials

  • Xavier ROBLIN, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

  • Sylvie PILLET, PhD

    CHU SAINT-ETIENNE

    STUDY DIRECTOR

Central Study Contacts

Xavier ROBLIN, MD PhD

CONTACT

(0)477828119xavier.roblin@chu-st-etienne.fr

Sylvie PILLET, PhD

CONTACT

(0)477828315sylvie.pillet@chu-st-etienne.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 24, 2019

Study Start

July 17, 2019

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)