Cytomegalovirus InfectionsRECOHFERRONNCT04030676

QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis

A study testing Biopsies and Blood samples in people with Cytomegalovirus Infections, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cytomegalovirus Infections
What is being tested?: Biopsies and Blood samples
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 196 participants
Where: 2 sitesFrance
Study dates: 17 Jul 2019to Apr 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Wardship patient and curatorial patient
Patient unable to understand or sign the protocol
Colectomy total or partial

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xavier ROBLIN, MD PhD contact

(0)477828119 ext. +33

xavier.roblin@chu-st-etienne.fr

Sylvie PILLET, PhD contact

(0)477828315 ext. +33

sylvie.pillet@chu-st-etienne.fr

France2 sites, 2 recruiting

HCL-Hôpital Lyon Sud
Lyon
Stéphane NANCEY, MD PhD
Gilles BOSCHETTI, MD PhD
Recruiting
Chu Saint-Etienne
Saint-Etienne
Xavier ROBLIN, MD PhD
Pauline VEYRARD, MD
Recruiting

Other trials in France

About this study

Official title: Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)

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.

Read the 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.

Conditions: Cytomegalovirus Infections
Being tested: Biopsies, Blood samples
Keywords: Immune response against, QuantiFERON-CytoMegaloVirus (QF-CMV), Ulcerative Colitis (UC), CytoMegaloVirus (CMV), quantitative PolymeraseChainReaction (qPCR), ImmunoHistoChemistry (IHC)
Medical subject headings: Cytomegalovirus Infections, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BiopsiesProcedure or surgery
Two more biopsies in inflammatory zone will be collected.
Blood samplesBiological
Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.

Study groups in NCT04030676
Study group	Role	What they receive
QuantiFERON Test	Experimental	Patient with CytoMegaloVirus (CMV) infection will be included. They will have biopsies and blood samples, composite of QuantiFERON-CytoMegaloVirus (QF-CMV) assay. Receives: Procedure: Biopsies; Biological: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: At the inclusion

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: At 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 2019Apr 2026

First posted24 Jul 2019
Study start17 Jul 2019
Primary completionJan 2026 (estimated)
Study completionApr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 196 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04030676
Sponsor's protocol ID: 18CH053
Other IDs: 2018-A01622-53
Acronym: RECOHFERRON
Status last verified: Apr 2025
First submitted: 19 Jul 2019
Last updated: 29 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Xavier ROBLIN, MD PhD

(0)477828119 ext. +33

xavier.roblin@chu-st-etienne.fr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
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RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

All Cytomegalovirus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
Acronym / sponsor ID: RECOHFERRON / 18CH053
Conditions: Cytomegalovirus Infections
Keywords: Immune response against, QuantiFERON-CytoMegaloVirus (QF-CMV), Ulcerative Colitis (UC), CytoMegaloVirus (CMV), quantitative PolymeraseChainReaction (qPCR), ImmunoHistoChemistry (IHC)
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 196 participants (estimated)
Lead sponsor: Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
Study start: 17 Jul 2019 (actual)
Primary completion: Jan 2026 (estimated)
Study completion: Apr 2026 (estimated)
First posted: 24 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
QuantiFERON Test	Experimental	Procedure: Biopsies, Biological: Blood samplesPatient with CytoMegaloVirus (CMV) infection will be included. They will have biopsies and blood samples, composite of QuantiFERON-CytoMegaloVirus (QF-CMV) assay.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Wardship patient and curatorial patient
Patient unable to understand or sign the protocol
Colectomy total or partial

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BiopsiesTwo more biopsies in inflammatory zone will be collected.	Procedure or surgery	QuantiFERON Test
Blood samplesBlood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.	Biological	QuantiFERON Test

Primary outcome

Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells
Time frame: 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
Time frame: 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.

3 secondary outcomes

Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue
Time frame: At the inclusion
Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC)
Time frame: At the inclusion
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood
Time frame: At 14 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
Individual participant dataSharing planned: No

Related trials for Cytomegalovirus Infections

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Xavier ROBLIN, MD PhD contact

(0)477828119 ext. +33

xavier.roblin@chu-st-etienne.fr

Sylvie PILLET, PhD contact

(0)477828315 ext. +33

sylvie.pillet@chu-st-etienne.fr

Xavier ROBLIN, MD PhD principal investigator

Centre Hospitalier Universitaire de Saint Etienne

Sylvie PILLET, PhD study director

Centre Hospitalier Universitaire de Saint Etienne

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biopsies and Blood samples in people with Cytomegalovirus Infections, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xavier ROBLIN, MD PhD ((0)477828119 ext. +33, xavier.roblin@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells (time frame: At the inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04030676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.