QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis
Recruiting · NCT04030676 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
View the official record on ClinicalTrials.gov →Interventions studied
BiopsiesBlood samples
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
2 locations listed.
- HCL-Hôpital Lyon Sud - Lyon, France
- Chu Saint-Etienne - Saint-Etienne, France