Immunotyping lymph nodes in IBD

Academic Medical Center0 个研究点目标入组 64 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•Inclusion criteria IBD patients:
•- Age 18-80 years
•- Additional for aim 1 (GALT tissue sampling): Patients with CD undergoing ileocecal resection because of (inflammatory or fibrotic) stenosis or extensive inflammation or therapy refractory disease
•Inclusion criteria healthy controls (Aim 1)
•- Patients undergoing cholecystectomy in the non-acute setting (symptomatic gall stone disease), without active inflammation
•- Negative for inflammatory bowel pathologies. - Age 18-80 years.

•Exclusion criteria IBD patients:
•- Patients, who are not able to provide informed consent.
•- History of malignancy
•- Viral or bacterial infection within the past 4 weeks
•- Patients using anticoagulant therapy
•- Present or previous use of systemic corticosteroids less than 28 days before enrollment
•- For aim 1: Present or previous use up to 3 months before enrolement of general immunosuppressive agents (e.g. Azathioprine, Methotrexate, Mycophenolate Mofetil) or biological treatments
•Exclusion criteria control patients (undergoing cholecystectomy (Aim 1):
•- Presence of intestinal inflammatory conditions (e.g. active cholecystitis)
•- Presence of inflammatory bowel disease
•- Individuals using anticoagulant therapy
•- Present or previous use of systemic glucocorticoids less than 28 days before enrolment
•- Present or previous use of experimental drugs
•- Present or previous treatment with any cell depleting therapies, including investigational agents
•- Presence of any disease for which study subjects need chronic or intermittent immunosuppressive therapy (e.g. prednisolone).
•- History of chronic viral infection
•- Recent (<1 week) bacterial or viral infection
•NL76643.018.21 / Immunotyping lymph nodes in IBD
•Version number: 2.0 ,date: 07/04/2021 15 of 30
•- History of autoimmune disease
•- History of malignancy
•- Individuals, who are not able to provide informed consent

发起方

Academic Medical Center