Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Testing a blood assay to predict Cytomegalovirus reactivation in Ulcerative Colitis patients

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

Run by Centre Hospitalier Universitaire de Saint Etienne · NCT04030676 · Data updated 2026-11-12

This study is testing a blood test to see if it can help predict when people with Ulcerative Colitis might have a Cytomegalovirus reactivation, so they can avoid unnecessary biopsies.

More Cytomegalovirus Infections trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment196 (estimated)
SponsorCentre Hospitalier Universitaire de Saint Etienne
Academic / other
Locations2 sites (Lyon and 1 other locations)
StatusRecruiting
StartedJuly 17, 2019
Main results expectedJanuary 2026
Study endsApril 2026
Registry record updatedApril 29, 2025
Trial IDNCT04030676 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are hospitalized patients with Ulcerative Colitis who are seropositive for Cytomegalovirus and have a significant flare-up.

Probably not a fit

Patients who have undergone total or partial colectomy or those unable to understand or sign the protocol may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the QuantiFERON-CytoMegaloVirus (QF-CMV) assay, which measures the immune response to Cytomegalovirus (CMV) in blood samples, to predict the risk of CMV reactivation in patients with Ulcerative Colitis (UC). By comparing the QF-CMV results with traditional invasive biopsies that assess CMV DNA load, the study aims to develop a new algorithm for managing UC patients that could reduce unnecessary biopsies. If the QF-CMV assay is positive, it indicates protection against CMV reactivation, while a negative result would prompt further invasive testing. This approach could streamline patient care and improve treatment outcomes.

Why it matters

Potential benefit: If successful, this study could lead to a less invasive and more efficient method for managing Cytomegalovirus reactivation in Ulcerative Colitis patients.

How similar studies have gone: While the approach of using immune response assays is gaining traction, this specific application of the QF-CMV assay in Ulcerative Colitis is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • HCL-Hôpital Lyon Sud
    Lyon, France
    Recruiting
  • Chu Saint-Etienne
    Saint-Etienne, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.