ASsoCiation bEtween seRum and Tissue protein profiles in pAtients wIth iNflammatory bowel disease: the ASCERTAIN trial

ASsoCiation bEtween seRum and Tissue protein profiles in pAtients wIth iNflammatory bowel disease: the ASCERTAIN trial - ASCERTAIN trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45257

Enrollment

Registered

2017-03-09

Start date

2017-04-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease inflammatory bowel disease ulcerative colitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Patients * 18 years 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 an endoscopy (ileo-, colonoscopy, sigmoidoscopy), independent of this study 5. Active disease, defined by either clinical or biochemical and endoscopic signs: 5.1 Clinical OR biochemical: 5.1.1 Clinical: CD: Harvey Bradshaw index (HBI) > 4. UC: simple clinical colitis activity index (SCCAI) * 5. 5.1.2 Biochemical: CRP > 5 mg/L or fecal calprotectin (FC) > 250 mcg/g). AND 5.2 Endoscopic signs of active disease: CD: * 1 ulcer * 0.5 cm. UC: Mayo score * 1

Exclusion criteria

Exclusion criteria: 1. Age

Design outcomes

Primary

Measure	Time frame
1. Primary objective: 1.2 To assess the correlation of protein profiles between intestinal tissue and serum in patients with IBD	—

Secondary

Measure	Time frame
2. Secondary Objectives: 2.1 To identify the source matrix that has the highest chance to yield clinically relevant IBD biomarkers in future research 2.2 To identify putative candidate biomarkers that are able to: 2.2.1 differentiate between IBD and non-IBD controls 2.2.2 differentiate between CD and UC 2.2.3 identify subgroups within the patients groups of CD or UC in alignment with endoscopic severity. 2.3 To identify possible targets for the future development of therapeutic compounds	—

Measure

Time frame

2. Secondary Objectives: 2.1 To identify the source matrix that has the highest chance to yield clinically relevant IBD biomarkers in future research 2.2 To identify putative candidate biomarkers that are able to: 2.2.1 differentiate between IBD and non-IBD controls 2.2.2 differentiate between CD and UC 2.2.3 identify subgroups within the patients groups of CD or UC in alignment with endoscopic severity. 2.3 To identify possible targets for the future development of therapeutic compounds

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Countries

Netherlands

Outcome results