Testing a blood assay to predict Cytomegalovirus reactivation in Ulcerative Colitis patients
Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 2 sites (Lyon and 1 other locations) |
| Trial ID | NCT04030676 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients with Ulcerative Colitis who are seropositive for Cytomegalovirus and have a significant flare-up.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lyon and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.