Cytomegalovirus Infections
Conditions
Keywords
Immune response against, QuantiFERON-CytoMegaloVirus (QF-CMV), Ulcerative Colitis (UC), CytoMegaloVirus (CMV), quantitative PolymeraseChainReaction (qPCR), ImmunoHistoChemistry (IHC)
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBiopsies
Two more biopsies in inflammatory zone will be collected.
BIOLOGICALBlood samples
Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells | 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. |
| QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood | 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
| Measure | Time frame | Description |
|---|---|---|
| Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) | At the inclusion | To evaluate the concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) analysis. |
| QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood | At 14 weeks | To compare measure of the QuantiFERON-CytoMegaloVirus (QF-CMV) assay at the flare-up and 14 weeks after. |
| Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue | 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. |
Countries
France
Contacts
Primary ContactXavier ROBLIN, MD PhD
Backup ContactSylvie PILLET, PhD
Outcome results
None listed