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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 196 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 2 sites (Lyon and 1 other locations) |
| Status | Recruiting |
| Started | July 17, 2019 |
| Main results expected | January 2026 |
| Study ends | April 2026 |
| Registry record updated | April 29, 2025 |
| Trial ID | NCT04030676 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
- Principal investigator: Xavier ROBLIN, MD PhD — Centre Hospitalier Universitaire de Saint Etienne
- Study coordinator: Xavier ROBLIN, MD PhD
- Email: xavier.roblin@chu-st-etienne.fr
- Phone: (0)477828119
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CMV-specific T cells after CMV reactivation in adults after HSCT
This study tests CMV-specific immune recovery in adults who have their first CMV reactivation after an allogeneic HSCT to see how CMV-specific T cells change over time.
-
Biomarkers linked to congenital CMV using newborn blood spots
Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.
-
T-cell–guided letermovir stopping after allogeneic stem cell transplant
This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.
-
Family-donor viral CTLs plus standard care vs standard care alone for refractory ADV or CMV infection after stem cell transplant
This study tests whether using family-donor virus-specific CTLs in addition to usual treatment helps children, teens, and young adults with hard-to-treat CMV or adenovirus infections after a stem cell transplant.
-
CMV-specific immunoglobulin to prevent CMV problems in children getting allogeneic stem cell transplants
Doctors will try giving CMV-specific immunoglobulin to children having allogeneic stem cell transplants to prevent CMV reactivation and related transplant complications.
-
R-MVST cell therapy for viral infections in children and young adults
This will try giving rapidly generated virus-specific T cells (R-MVST) to children and young adults whose weakened immune systems have recurrent or treatment-resistant infections with EBV, CMV, adenovirus, or BK virus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.