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Correlation of a predefined set of 96 inflammatory proteins between the serum and intestinal tissue within patients with inflammatory bowel disease


- candidate number27150
- NTR NumberNTR6440
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2017
- Secondary IDs2016_344 Medisch Ethische Commissie, Academisch Medisch Centrum Amsterdam
- Public TitleCorrelation of a predefined set of 96 inflammatory proteins between the serum and intestinal tissue within patients with inflammatory bowel disease
- Scientific TitleASsoCiation bEtween seRum and Tissue protein profiles in pAtients wIth iNflammatory bowel disease
- ACRONYMASCERTAIN
- hypothesisMost studies that aimed to discover new IBD biomarkers on a protein level have mainly focused on plasma/serum. However, recent studies suggest that analysing material closer to or directly from the location of disease may yield higher concentrations of potential biomarkers. However, although the diseased intestine itself may contain increased protein concentrations and facilitate biomarker discovery, the use of this material in routine care is limited due to the invasive nature of the procedure. Therefore, matched validation of candidate markers in serum is required. We aim to investigate the correlation between the protein profiles of the serum and the gut mucosa.
- Healt Condition(s) or Problem(s) studiedIBD, Inflammatory bowel disease
- Inclusion criteria1. Patients °› 18 years old
2. Diagnosis of IBD, based on a combination of history, physical examination, family history, laboratory tests, endoscopy tests including histopathologic examination of mucosal biopsies, imaging studies and occasionally intraoperative findings
3. Written informed consent
4. The clinical indication for a colonoscopy, independent of this study
5. Active disease, defined by either clinical or biochemical AND endoscopic signs:
5.1 Clinical OR biochemical signs of active disease
5.1.1 Clinical:
5.1.1.1 CD: Harvey Bradshaw index (HBI) [21] > 4
5.1.1.2 UC: simple clinical colitis activity index (SCCAI) [22] °› 5
5.1.2 Biochemical:
5.1.2.1 CRP > 5 mg/L or fecal calprotectin (FC) > 250 mcg/g)
AND
5.2 Endoscopic signs of active disease
5.2.1 CD: °› 1 ulcer °› 0.5 cm
5.2.2 UC: Mayo score [7] °› 1
- Exclusion criteria1. Age < 18 years at inclusion
2. Ongoing use of anticoagulants that may increase the risk of bleeding when biopsies are taken
3. Currently ongoing malignancy
4. Serious concomitant inflammatory diseases and/or anti-inflammatory treatment(s) that may impair the interpretability of the protein analysis, per investigators°Į interpretation (e.g. microscopic colitis)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate12-dec-2017
- Target number of participants92
- Interventionsprocurement of 5 intestinal biopsies
1 5mL serum tube withdrawal
- Primary outcomeTo assess the correlation of protein profiles between intestinal tissue and serum in patients with IBD
- Secondary outcomeTo identify the source matrix that has the highest chance to yield clinically relevant IBD biomarkers in future research
To identify putative candidate biomarkers that are able to:
o differentiate between IBD and non-IBD controls
o differentiate between CD and UC
o identify subgroups within the patients groups of CD or UC in alignment with endoscopic severity.
To identify possible targets for the future development of therapeutic compounds
- TimepointsCross sectional
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD candidate Toer W. Stevens
- CONTACT for SCIENTIFIC QUERIESMD, PhD candidate Toer W. Stevens
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryInflammatory bowel disease (IBD) comprise two major entities of chronic intestinal disorders: Crohn°Įs disease (CD) and ulcerative colitis (UC). The ongoing expansion in the therapeutic armamentarium for IBD has improved therapeutic outcome for many patients. However, both CD and UC are highly heterogenic conditions, both in clinical presentation and in response to therapy. It remains difficult to predict which patient is likely to respond to a particular treatment at any given stage of their disease. To optimize the use of currently available therapeutic interventions, a more personalized diagnostic and therapeutic care-path is needed. Currently it may take several years to find an effective treatment for an individual patient. Hence, from both a patient and a pharmaco-economic point of view, predictive biomarkers for therapy response would be of great benefit. Most studies that aimed to discover new IBD biomarkers on a protein level have mainly focused on plasma/serum. However, recent studies suggest that analysing material closer to or directly from the location of disease may yield higher concentrations of potential biomarkers. However, although the diseased intestine itself may contain increased protein concentrations and facilitate biomarker discovery, the use of this material in routine care is limited due to the invasive nature of the procedure. Therefore, matched validation of candidate markers in serum is required. We aim to investigate the correlation between the protein profiles of the serum and the gut mucosa.
- Main changes (audit trail)
- RECORD1-mei-2017 - 29-jun-2017


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