|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
27 November 2023 |
|
Main ID: |
NCT03172195 |
|
Date of registration:
|
23/05/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
VIRCH |
|
Scientific title:
|
Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up |
|
Date of first enrolment:
|
October 11, 2017 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03172195 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Xavier ROBLIN, MD PhD |
|
Address:
|
|
|
Telephone:
|
(0)477828119 |
|
Email:
|
xavier.roblin@chu-st-etienne.fr |
|
Affiliation:
|
|
|
|
Name:
|
Xavier Roblin, MD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU SAINT-ETIENNE |
|
|
Name:
|
Xavier Roblin, MD PhD |
|
Address:
|
|
|
Telephone:
|
(0)477828119 |
|
Email:
|
xavier.roblin@chu-st-etienne.fr |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Colitis, Ulcerative
|
|
Intervention(s)
|
|
Biological: blood sample
|
|
Biological: biopsies
|
|
Procedure: rectosigmoidoscopy
|
|
Primary Outcome(s)
|
|
Number of patients with different viral load in the colonic mucosa
[Time Frame: day 1]
|
|
Secondary Outcome(s)
|
|
Correlation of the different viral loads with the anti-TNF treatment response
[Time Frame: up to 24 months]
|
|
Correlation of the different viral loads with the Mayo endoscopic score
[Time Frame: Day 1]
|
|
Correlation of the different viral loads with the steroid treatment response
[Time Frame: up to 24 months]
|
|
Secondary ID(s)
|
|
1708033
|
|
ANSM
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|