QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis
Not applicable · Testing Biopsies and Blood samples · 2 sites · Centre Hospitalier Universitaire de Saint Etienne
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Biopsies (a procedure) and Blood samples (a biologic) as a way to diagnose or measure disease. Condition(s) listed: Cytomegalovirus Infections.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 196 participants are expected to take part.
- Start date: 2019-07-17.
- Main results expected around 2026-01 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in France.
Main thing being measured
- Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells (At the inclusion)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Cytomegalovirus Infections |
| Lead sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Enrollment | 196 (estimated) |
| Start date | 2019-07-17 |
| Primary completion (est.) | 2026-01 |
| First posted | 2019-07-24 |
| Last updated | 2025-04-29 |
| Official title | Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC) |
| ClinicalTrials.gov ID | NCT04030676 |
Interventions
- Biopsies (Procedure)
Two more biopsies in inflammatory zone will be collected. - Blood samples (Biological)
Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.
Full eligibility criteria (from the record)
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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| HCL-Hôpital Lyon Sud | Lyon | France | Recruiting |
| Chu Saint-Etienne | Saint-Etienne | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.