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Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up (VIRCH)

Primary Purpose

Colitis, Ulcerative

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rectosigmoidoscopy
biopsies
blood sample
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 Colitis, Ulcerative focused on measuring ulcerative colitis, inflammation, immunosuppressive drugs, herpesvirus, qPCR, colonic mucosa

Eligibility Criteria

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

Inclusion Criteria:

  • Age>18 years
  • Voluntary to participate to the study
  • Flare-up of ulcerative colitis with Mayo score >6
  • Ability to receive steroid or anti-TNF therapy
  • Agree the rectosigmoidoscopy and the therapies

Exclusion Criteria:

  • Age <18 years
  • Pregnancy
  • Disagree the rectosigmoidoscopy or the therapies
  • Participation to the evaluation of a new therapy
  • Colectomy (partial or total)
  • Contraindication of steroid or anti-TNF therapy
  • Anticoagulant drugs

Sites / Locations

  • CHU Saint-EtienneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with ulcerative colitis

Arm Description

Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample.

Outcomes

Primary Outcome Measures

Number of patients with different viral load in the colonic mucosa
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa

Secondary Outcome Measures

Correlation of the different viral loads with the Mayo endoscopic score
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa The Mayo endoscopic score integrate the severity from lesions of colonic mucosa measured by rectosigmoidoscopy
Correlation of the different viral loads with the steroid treatment response
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa. Steroid treatment response is defined by clinic mayo score < 3 measured by rectosigmoidoscopy.
Correlation of the different viral loads with the anti-TNF treatment response
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa. anti-TNF treatment response is defined by clinic mayo score < 3 measured by rectosigmoidoscopy.

Full Information

First Posted
May 23, 2017
Last Updated
October 3, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03172195
Brief Title
Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
Acronym
VIRCH
Official Title
Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (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
Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. In previous studies, the active role of cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex) together with that of CMV in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe UC flare-up (Mayo score >6 with endoscopic score higher or equal than 2). The viral load will also be correlated to the Mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
ulcerative colitis, inflammation, immunosuppressive drugs, herpesvirus, qPCR, colonic mucosa

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Patients with ulcerative colitis
Arm Type
Experimental
Arm Description
Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample.
Intervention Type
Procedure
Intervention Name(s)
rectosigmoidoscopy
Intervention Description
A rectosigmoidoscopy will be realized and two fragments will be collected.
Intervention Type
Biological
Intervention Name(s)
biopsies
Intervention Description
For this study, two biopsies in healthy area and two biopsies in ulcer will be collected.
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
Blood sample will be collected in more.
Primary Outcome Measure Information:
Title
Number of patients with different viral load in the colonic mucosa
Description
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Correlation of the different viral loads with the Mayo endoscopic score
Description
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa The Mayo endoscopic score integrate the severity from lesions of colonic mucosa measured by rectosigmoidoscopy
Time Frame
Day 1
Title
Correlation of the different viral loads with the steroid treatment response
Description
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa. Steroid treatment response is defined by clinic mayo score < 3 measured by rectosigmoidoscopy.
Time Frame
up to 24 months
Title
Correlation of the different viral loads with the anti-TNF treatment response
Description
Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV. It will be measured by Polymerase Chain Reaction technical in colonic mucosa. anti-TNF treatment response is defined by clinic mayo score < 3 measured by rectosigmoidoscopy.
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age>18 years Voluntary to participate to the study Flare-up of ulcerative colitis with Mayo score >6 Ability to receive steroid or anti-TNF therapy Agree the rectosigmoidoscopy and the therapies Exclusion Criteria: Age <18 years Pregnancy Disagree the rectosigmoidoscopy or the therapies Participation to the evaluation of a new therapy Colectomy (partial or total) Contraindication of steroid or anti-TNF therapy Anticoagulant drugs
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
Florence RANCON, CRA
Phone
(0)477829458
Ext
+33
Email
florence.rancon@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
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier ROBLIN, MD PhD
Phone
(0)477828119
Ext
+33
Email
xavier.roblin@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Emilie DEL TEDESCO, MD
First Name & Middle Initial & Last Name & Degree
Xavier ROBLIN, MD PhD
First Name & Middle Initial & Last Name & Degree
Nicolas WILLIET, MD
First Name & Middle Initial & Last Name & Degree
Sylvie PILLET, MD
First Name & Middle Initial & Last Name & Degree
Bruno POZZETTO, MD PhD
First Name & Middle Initial & Last Name & Degree
Pauline VEYRARD, MD
First Name & Middle Initial & Last Name & Degree
Laëtitia BASTIDE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up

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