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

Primary Purpose

Cytomegalovirus Infections

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsies
Blood samples
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cytomegalovirus Infections focused on measuring Immune response against, QuantiFERON-CytoMegaloVirus (QF-CMV), Ulcerative Colitis (UC), CytoMegaloVirus (CMV), quantitative PolymeraseChainReaction (qPCR), ImmunoHistoChemistry (IHC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HCL-Hôpital Lyon SudRecruiting
  • Chu Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QuantiFERON Test

Arm Description

Patient with CytoMegaloVirus (CMV) infection will be included. They will have biopsies and blood samples, composite of QuantiFERON-CytoMegaloVirus (QF-CMV) assay.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 19, 2019
Last Updated
April 14, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT04030676
Brief Title
QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis
Acronym
RECOHFERRON
Official Title
Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
Keywords
Immune response against, QuantiFERON-CytoMegaloVirus (QF-CMV), Ulcerative Colitis (UC), CytoMegaloVirus (CMV), quantitative PolymeraseChainReaction (qPCR), ImmunoHistoChemistry (IHC)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QuantiFERON Test
Arm Type
Experimental
Arm Description
Patient with CytoMegaloVirus (CMV) infection will be included. They will have biopsies and blood samples, composite of QuantiFERON-CytoMegaloVirus (QF-CMV) assay.
Intervention Type
Procedure
Intervention Name(s)
Biopsies
Intervention Description
Two more biopsies in inflammatory zone will be collected.
Intervention Type
Biological
Intervention Name(s)
Blood samples
Intervention Description
Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.
Primary Outcome Measure Information:
Title
Quantification of CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load (quantitative PolymeraseChainReaction (qPCR) analysis) in the inflammatory tissue - UI/100 000 cells
Description
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
Title
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood
Description
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
Secondary Outcome Measure Information:
Title
Total number of cells infected by CMV (/mm2) by ImmunoHistoChemistry (IHC) in the inflammatory tissue
Description
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
Title
Concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC)
Description
To evaluate the concordance of the results between quantitative PolymeraseChainReaction (qPCR) and ImmunoHistoChemistry (IHC) analysis.
Time Frame
At the inclusion
Title
QuantiFERON-CytoMegaloVirus (QF-CMV) test result (UI/ml) in blood
Description
To compare measure of the QuantiFERON-CytoMegaloVirus (QF-CMV) assay at the flare-up and 14 weeks after.
Time Frame
At 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier ROBLIN, MD PhD
Phone
(0)477828119
Ext
+33
Email
xavier.roblin@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie PILLET, PhD
Phone
(0)477828315
Ext
+33
Email
sylvie.pillet@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier ROBLIN, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sylvie PILLET, PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Study Director
Facility Information:
Facility Name
HCL-Hôpital Lyon Sud
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane NANCEY, MD PhD
First Name & Middle Initial & Last Name & Degree
Gilles BOSCHETTI, MD PhD
First Name & Middle Initial & Last Name & Degree
Claire GAY, MD
First Name & Middle Initial & Last Name & Degree
Bernard FLOURIE, MD
First Name & Middle Initial & Last Name & Degree
Pauline DANION, MD
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier ROBLIN, MD PhD
First Name & Middle Initial & Last Name & Degree
Pauline VEYRARD, MD
First Name & Middle Initial & Last Name & Degree
Emilie DEL TEDESCO, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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