Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01861288
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2013-05-17
Brief Title:
Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With Inflammatory Bowel Disease
Sponsor:
Herlev Hospital
Organization:
Herlev Hospital
Study Overview
Official Title:
Development of a New Algorithm to Determine the Activity of Disease Deep Endoscopic Remission Assessed by a Surrogate Biomarker in Patients With IBD
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We hypothesize that the number of needed endoscopic procedure performed at IBD patients adult and children can be reduced by using an individualized algorithm of symptoms blood and faecal biomarkers
The aim of the study is to reduce the numbers of endoscopies as the procedure is uncomfortable for the patient time consuming and expensive Through indirect tests - blood test fecal inflammation marker and clinical symptoms - compared to endoscopic findings we want to construct an algorithm by which the intestinal healing can be foreseen without performing an endoscopy
Furthermore we will correlate FC blood tests clinical symptom score and endoscopic score with the histo-pathological inflammation score from intestinal biopsies and the immunological score depicted by TNF- alpha and IL17A levels in intestinal tissue in order to assess the gold standard - endoscopic remission
The aim of the study is to reduce the numbers of endoscopies as the procedure is uncomfortable for the patient time consuming and expensive Through indirect tests - blood test fecal inflammation marker and clinical symptoms - compared to endoscopic findings we want to construct an algorithm by which the intestinal healing can be foreseen without performing an endoscopy
Furthermore we will correlate FC blood tests clinical symptom score and endoscopic score with the histo-pathological inflammation score from intestinal biopsies and the immunological score depicted by TNF- alpha and IL17A levels in intestinal tissue in order to assess the gold standard - endoscopic remission
Detailed Description:
Deep remission The treatment goal in patiens with IBD is to achieve deep remission before drug withdrawal to avoid relapse In order to evaluate the healing of mucosa it is currently necessary to carry out an endoscopy despite the additional information provided by FC and blood samples The endoscopic procedure is uncomfortable for the patient time consuming and expensive We therefore seek on the basis of existing knowledge and using a correlation between FC blood tests and clinical remission with endoscopic findings to establish some non-invasive biomarkers that might express deep remission In the long run threshold levels will be used as indicators for performing an endoscopy and hopefully reduce the need for it to be performed We will compare the results from children and adults because it is likely there exist differences in their respective FC levels
Histopathologic remission Biopsies of the intestinal tissue can be evaluated histopathologically and indicate the level of microscopic inflammation and can assess the acute and chronic inflammatory signs at the cellular level eg altered glandular structure crypt abscess and ulcerations By using the Karl Geboes grading system microscopic histopathological deep remission can be assessed We will explore the endoscopic gold standard by comparing endoscopic remission with histopathological remission
Immunological remission In general tissue factors are linked to various immunological pathways belonging to the innate adaptive and regulatory immune response comprising a pro-inflammatory and an anti-inflammatory response This includes molecules such as cytokines chemokines adhesion molecules and their corresponding cellular and soluble receptors Tumor-necrosis-factor TNF-alpha and interleukin 17A is two of several molecules in the pro-inflammatory process that is strongly associated with the grade of inflammation in IBD Florholmen and Fries 2011 Olsen et al 2009 have reported that a normalization of mucosal TNF-alpha in most ulcerative colitis patients will represent an endoscopically healed mucosa
In addition to clinical indexes endoscopic and histological criteria we also introduce a molecular based Immunological Remission A working hypothesis is that immunological remission is a state of normalization of the pro-inflammatory and anti-inflammatory processes in mucosa The concept of immunological remission and the potential clinical impact are still in the early phases of evaluation and to obtain a practical application a non-invasive test such as one based on a stool sample must be developed In the current project immunological remission will be a part of this study as endoscopic and histopathology remission with correlation to FC blood tests and clinical remission
Histopathologic remission Biopsies of the intestinal tissue can be evaluated histopathologically and indicate the level of microscopic inflammation and can assess the acute and chronic inflammatory signs at the cellular level eg altered glandular structure crypt abscess and ulcerations By using the Karl Geboes grading system microscopic histopathological deep remission can be assessed We will explore the endoscopic gold standard by comparing endoscopic remission with histopathological remission
Immunological remission In general tissue factors are linked to various immunological pathways belonging to the innate adaptive and regulatory immune response comprising a pro-inflammatory and an anti-inflammatory response This includes molecules such as cytokines chemokines adhesion molecules and their corresponding cellular and soluble receptors Tumor-necrosis-factor TNF-alpha and interleukin 17A is two of several molecules in the pro-inflammatory process that is strongly associated with the grade of inflammation in IBD Florholmen and Fries 2011 Olsen et al 2009 have reported that a normalization of mucosal TNF-alpha in most ulcerative colitis patients will represent an endoscopically healed mucosa
In addition to clinical indexes endoscopic and histological criteria we also introduce a molecular based Immunological Remission A working hypothesis is that immunological remission is a state of normalization of the pro-inflammatory and anti-inflammatory processes in mucosa The concept of immunological remission and the potential clinical impact are still in the early phases of evaluation and to obtain a practical application a non-invasive test such as one based on a stool sample must be developed In the current project immunological remission will be a part of this study as endoscopic and histopathology remission with correlation to FC blood tests and clinical remission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None