An interventional study of Biopsies and Blood samples in Cytomegalovirus Infections, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Diagnostic
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Among 48 studies in Cytomegalovirus Infections with a site in France — 10 open to participants now, 11 under way, 2 of them phase 3. Cytomegalovirus Infections · France.
Among the 48 studies in Cytomegalovirus Infections with a site in France, this one is the 13th largest by planned enrollment of the 33 interventional ones that give a count, is one of 6 that started in 2019, is one of 8 with no phase, reaches primary completion later than 1 of the 10 other live ones, and was the 28th registered.
370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.
Browse Cytomegalovirus Infections studies →10 of the 48 studies in Cytomegalovirus Infections with a site in France are open now. Recruiting first, the newest first:
University Hospital, Strasbourg, France · Sites in France
Ages 0 yrs–1 mo
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+ · Women only
University Hospital, Grenoble · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 1–100
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 35 Cytomegalovirus Infections studies recruiting now, 20 (57%) set no upper age limit and 13 (37%) stop at 75 or younger; 19 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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48 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 3 13 · Phase 4 5
First in 2004; this study’s year is marked. 6 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 196 is above the median of 64 across 240 interventional studies indexed under Cytomegalovirus Infections.
Median enrollment 100 across the 33 interventional studies, 250 across the 15 observational. Of the 36 that completed or were terminated, 8 (22%) have results posted.
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11 of 48 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
Centre Hospitalier Universitaire de Saint Etienne has 1 study filed under Cytomegalovirus Infections — fewer than ten, so there is no comparison to draw.
4 of the studies in Cytomegalovirus Infections with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06334497Phase 3Assistance Publique - Hôpitaux de ParisLetermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections | 2027-09 |
| NCT05701228University Hospital, BordeauxCasting Light on HOst-cytomegaloviRUs Interaction in Solid Organ Transplantation | 2026-12 |
| NCT05234723IRCCS Azienda Ospedaliero-Universitaria di BolognaGanciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients | 2027-02-28 |
| NCT06694428Assistance Publique - Hôpitaux de ParisEvaluation of Software for Interpreting Virological Results Indicated for the Diagnosis of Cytomegalovirus (CMV) Infection During Pregnancy and Intended for Health Professionals | 2027-04-04 |
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Among the 48 studies in Cytomegalovirus Infections with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with CytoMegaloVirus (CMV) infection will be included. They will have biopsies and blood samples, composite of QuantiFERON-CytoMegaloVirus (QF-CMV) assay.
Procedure: Biopsies · Biological: Blood samples
Two more biopsies in inflammatory zone will be collected.
Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.
Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells
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.
Time frame: At the inclusion
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood
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.
Time frame: At the inclusion
Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue
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.
Time frame: At the inclusion
Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC)
To evaluate the concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) analysis.
Time frame: At the inclusion
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood
To compare measure of the QuantiFERON-CytoMegaloVirus (QF-CMV) assay at the flare-up and 14 weeks after.
Time frame: At 14 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2019 (actual). Primary completion is estimated for Jan 2026, 78 months after the start.
Of 23 interventional studies with no phase under Cytomegalovirus Infections, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 56. This study's planned 78 months is above that.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Universitaire de Saint Etienne →