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NCT Number: NCT04030676

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

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.

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Key information

Conditions

Cytomegalovirus Infections Colitis Colitis, Ulcerative Colonic Diseases DNA Virus Infections Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Herpesviridae Infections Infections Inflammatory Bowel Diseases Intestinal Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HCL-Hôpital Lyon Sud, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsies

Procedure

Two more biopsies in inflammatory zone will be collected.

blood samples

Biological

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

Primary outcomes

  1. Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: At the inclusion

    To evaluate the concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) analysis.

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

    Time frame: At 14 weeks

    To compare measure of the QuantiFERON-CytoMegaloVirus (QF-CMV) assay at the flare-up and 14 weeks after.

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvie PILLET, PhD

CONTACT

[email protected]

(0)477828315 ext. +33

Xavier ROBLIN, MD PhD

CONTACT

[email protected]

(0)477828119 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: RECOHFERRON

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2019
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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